Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VEN

Summary

The FDA issued a Class II for Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WH by Healthmark Industries Co., Inc.. Reason: Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated..

Details

Product Description

Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE, Model Number 09-1-012; 4) BLUE VENTED INSTRUMENT GUARD 5/64 X 3/4, Model Number 09-1-012; 5) VENTED INSTRUMENT GUARD 7/64 X 3/4 - GREEN, Model Number 09-1-013; 6) GREEN VENTED INSTRUMENT GUARD 7/64 X 3/4, Model Number 09-1-013; 7) VENTED INSTRUMENT GUARD 1/8 X 1 - RED, Model Number 09-1-014; 8) RED VENTED INSTRUMENT GUARD 1/8 X 1, Model Number 09-1-014; 9) VENTED INSTRUMENT GUARD 3/16 X 1 - YELLOW, Model Number 09-1-015; 10) YELLOW VENTED INSTRUMENT GUARD 3/16 X 1, Model Number 09-1-015; 11) VENTED INSTRUMENT GUARD 13/32 X 3/4 - MAROON, Model Number 09-1-016; 12) MAROON VENTED INSTRUMENT GUARD 13/32 X 3/4, Model Number 09-1-016; 13) MAROON VENTED INSTRU GUARD 13/32 X 3/4, Model Number 09-1-016; 14) VENTED INSTRUMENT GUARD 1/16 X 3/8 X 1 - ORANGE, Model Number 09-1-017; 15) ORANGE VENTED INSTRUMENT GUARD 1/16 X 3/8 X 1, Model Number 09-1-017; 16) OR VENTED INSTRU GUARD 1/16 X 3/8 X 1, Model Number 09-1-017; 17) VENTED INSTRUMENT GUARD 5/64 X 5/8 X 1 - BROWN, Model Number 09-1-018; 18) BROWN VENTED INSTRUMENT GUARD 5/64 X 5/8 X 1, Model Number 09-1-018; 19) BROWN VENTED INSTRU GUARD 5/64 X 5/8 X 1, Model Number 09-1-018; 20) VENTED INSTRUMENT GUARD 1/8 X 1 X 1 - BLACK, Model Number 09-1-019; 21) BLACK VENTED INSTRUMENT GUARD 1/8 X 1 X 1, Model Number 09-1-019; 22) BLACK VENTED INSTRU GUARD 1/8 X 1 X 1, Model Number 09-1-019; 23) OPAQUE ASSORTED VENTED INSTRUMENT GUARDS, Model Number 09-1-020; 24) OPAQUE COLOR - ASSORTED VENTED INSTRUMENT GUARDS, Model Number 09-1-020; 25) VENTED INSTRUMENT GUARD 1/16 X 3/4 - TRANSPARENT BLUE, Model Number 09-2-011;

Lot/Code Info: Model Number 09-1-011, UDI DI 00840113213610, Lot Number 46313; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 48704; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 52563; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 54316; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 56859; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 62805; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 66222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 68451; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 70818; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 76638; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 77955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 85979; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 88504; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 091011; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 92954; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 93535; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 95456; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 96593; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 99366; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 103829; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 107222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 112086; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 116183; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 125652; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 130885; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 141843; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 145497; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 149058; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 154671; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 161613; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 166797; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 168628; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 175315; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 181731; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 187198; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 188727; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 197096; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 201659; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 201659; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 202330; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 205350; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 205390; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 212318; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 212526; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 218245; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 221829; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 222154; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 223718; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 229372; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 231155; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 235520; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 236774; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 240155; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 242716; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 246432; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 247558; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 249963; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 251383; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 255148; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 258946; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 260731; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 264390; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 268142; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 283481; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 285927; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 286004; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 291423; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 294844; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 297200; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 299094; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 306959; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 309214; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 312858; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 312892; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 319749; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 340090; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 343009; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 350257; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 351368; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 357006; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 360264; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 360718; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 364439; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 367841; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 368200; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 372245; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 372770; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 374801; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 374847; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 385955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 388236; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 393457; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 443178; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 443178; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 462400; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 462400; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 493002; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 100000591; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 103829; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 107222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 112086; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 125652; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 54316; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 56859; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 77955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 93535; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 99366; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 240155; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 286004; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 291423; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 368200; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 091011; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 48704; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 68451; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 81204; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 258946; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 340090; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 350257; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 187198; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 52563; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 62805; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 66222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 70818; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 76638; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 283481; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 351368; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 247558; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 255148; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 360718; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 212526; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 312892; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 319749; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 149058; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 343009; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 218245; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 388236; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 294844; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 306959; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 360264; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 188727; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 175315; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 462400; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 201659; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 264390; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 372245; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 374801; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 141843; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 130885; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 268142; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 364439; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 116183; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 385955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 145497; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 161613; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 44095; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 49677; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 51509; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 54643; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 56860; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 58148; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 62394; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 62634; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 68585; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 70021; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 76649; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 79457; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 81514; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 86249; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 90304; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 091012; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 95567; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 101994; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 104403; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 108216; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 114714; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 120256; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 124928; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 128783; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 137736; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 137737; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 146848; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 148709; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 151248; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 154714; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 158427; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 160077; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 168636; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 174867; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 185284; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 193382; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 195843; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 201660; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 201660; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 205443; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 213869; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 214458; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 221383; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 224061; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 224341; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 224440; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 224461; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 229250; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 233593; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 240154; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 245111; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 247200; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 249976; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 250613; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 255573; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 259566; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 259702; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 267616; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 269041; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 272360; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 283322; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 293675; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 298472; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 299164; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 300628; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 304910; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 306160; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 307347; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 311278; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 314508; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 322160; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 322686; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 345072; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 346879; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 351042; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 359697; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 360766; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 365636; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 377095; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 383414; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 385957; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 399033; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 423307; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 446247; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 446247; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 446247; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 100000593; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 298472; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 446247; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 101994; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 104403; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 51509; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 62394; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 68585; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 86249; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 90304; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 95567; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 259566; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 44095; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 54643; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 58148; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 76649; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 300628; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 345072; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 346879; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 385381; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 193382; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 267616; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 124928; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 174867; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 70021; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 205443; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 62634; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 245111; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 168636; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 214458; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 359697; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 365636; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 293675; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 185284; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 201660; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 351042; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 146848; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 259702; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 158427; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 120256; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 314508; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 148709; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 272360; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 114714; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 311278; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 399033; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 360766; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 137737; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 151248; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 385957; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 249976; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 39949; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 46134; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 55036; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 56244; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 66210; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 71367; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 76618; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 78159; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 83547; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 87013; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 091013; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 91598; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 94868; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 96555; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 98034; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 106260; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 112523; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 116359; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 118813; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 122489; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 125628; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 137727; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 139930; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 141844; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 143143; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 149435; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 154761; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 158252; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 163075; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 172695; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 176864; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 185836; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 187861; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 189808; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 194693; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 196682; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 198249; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 199843; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 201856; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 201856; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 203626; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 205073; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 208844; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 214124; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 218518; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 221078; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 223251; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 225213; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 230079; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 232062; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 234015; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 238036; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 239193; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 242706; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 245657; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 246701; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 255300; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 255831; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 263575; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 265558; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 273449; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 278634; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 279994; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 288466; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 299099; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 301868; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 304798; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 306171; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 306523; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 311412; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 313393; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 316418; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 318502; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 323402; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 327003; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 330090; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 335237; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 337312; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 340586; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 347694; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 348427; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 351041; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 352886; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 360263; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 361337; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 367845; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 369290; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 370076; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 370734; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 380012; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 385382; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 390306; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 391423; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 403678; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 450231; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 476335; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 478061; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 493476; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 100000540; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 100000592; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 3000541534; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 3000547916; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 3000550870; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 3000553940; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 214124; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 245657; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 246701; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 316418; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 347694; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 370076; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 390306; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 478061; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 39949; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 46134; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 98034; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 223251; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 255831; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 265558; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 306523; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 327003; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 194693; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 66210; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 71367; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 76618; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 78159; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 87013; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 225213; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 278634; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 370734; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 118813; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 56244; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 304798; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 391423; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 403678; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 139930; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 335237; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 091013; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 158252; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 205073; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 306171; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 141844; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 154761; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 311412; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 273449; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 277747; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 380012; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 368437; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 279994; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 351041; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 176864; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 352886; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 185836; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 367845; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 44507; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 48670; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 50630; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 52713; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 54571; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 60603; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 62531; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 63247; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 65925; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 67084; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 68314; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 71792; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 75487; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 75914; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 77421; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 77788; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 80262; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 81295; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 83614; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 87305; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 89251; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 091014; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 91100; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 91931; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 93992; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 97103; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 97173; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 99431; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 101610; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 104845; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 106039; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 112763; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 114495; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 116546; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 119216; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 120256; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 122796; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 130784; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 136181; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 139121; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 141669; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 143118; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 144376; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 144377; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 148304; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 152382; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 157789; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 161614; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 163211; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 163211; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 163521; Model Numbe

Quantity Affected: 12,835,920 units

Reason for Recall

Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-09-07

Company