Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY
Summary
The FDA issued a Class II for Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS by MEDLINE INDUSTRIES, LP - Northfield. Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging..
Details
Source
Device Recall
External ID
Z-1097-2023
Action Date
2023-02-15
Status
Ongoing
Category
device
Product Description
Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY PACK
Lot/Code Info: a. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS940869U, Case UDI/GTIN: 40195327210046, Unit UDI/GTIN: 10195327210045, Lot Number: 22JBR468,22JBA443; b. ARTHROSCOPY CDS, Item Number: CDS985208B, Case UDI/GTIN: 40889942942061, Unit UDI/GTIN: 10889942942060, Lot Number: 22JBR379,22IBS410,22IBO331,22IBO332; c. ARTHROSCOPY LV - EDOC PACK-LF, Item Number: DYNJ0111409L, Case UDI/GTIN: 40889942824015, Unit UDI/GTIN: 10889942824014, Lot Number: 22JMH535,22IMF440; d. ARTHROSCOPY PACK-LF, Item Number: DYNJ0376528J, Case UDI/GTIN: 40889942395935, Unit UDI/GTIN: 10889942395934, Lot Number: 22JBJ567; e. ARTHROSCOPY PACK, Item Number: DYNJ04446N, Case UDI/GTIN: 40888277753649, Unit UDI/GTIN: 10888277753648, Lot Number: 22JMH875,22HMG756; f. ARTHRO PACK-LF, Item Number: DYNJ0637509B, Case UDI/GTIN: 40889942079255, Unit UDI/GTIN: 10889942079254, Lot Number: 22IMH393; g. ARTHROSCOPY PACK-LF, Item Number: DYNJ0751097M, Case UDI/GTIN: 40195327196364, Unit UDI/GTIN: 10195327196363, Lot Number: 22HMC138; h. ARTHROSCOPY PACK-LF, Item Number: DYNJ0890114F, Case UDI/GTIN: 40889942824039, Unit UDI/GTIN: 10889942824038, Lot Number: 22JMC992,22IMG334; i. ARTHROSCOPY KNEE TRAY-LF, Item Number: DYNJ09577J, Case UDI/GTIN: 40889942104803, Unit UDI/GTIN: 10889942104802, Lot Number: 22IBJ738; j. ARTHROSCOPY PACK-LF, Item Number: DYNJ15916C, Case UDI/GTIN: 40888277861610, Unit UDI/GTIN: 10888277861619, Lot Number: 22KBA679,22JBS955; k. ARTHROSCOPY BASIN PACK-LF, Item Number: DYNJ16633C, Case UDI/GTIN: 40888277858450, Unit UDI/GTIN: 10888277858459, Lot Number: 22JBV974; l. ARTHROTOMY PACK-LF, Item Number: DYNJ19751B, Case UDI/GTIN: 40884389018423, Unit UDI/GTIN: 10884389018422, Lot Number: 22IME726; m. ARTHROSCOPY PACK-LF, Item Number: DYNJ24861D, Case UDI/GTIN: 40888277545398, Unit UDI/GTIN: 10888277545397, Lot Number: 22JBJ980,22JBG368; n. ARTHROSCOPY PACK, Item Number: DYNJ26870I, Case UDI/GTIN: 40889942605669, Unit UDI/GTIN: 10889942605668, Lot Number: 22IBN707; o. ARTHROSCOPY PACK, Item Number: DYNJ30719C, Case UDI/GTIN: 40888277077745, Unit UDI/GTIN: 10888277077744, Lot Number: 22JBW329; p. ARTHROSCOPY PACK, Item Number: DYNJ31889C, Case UDI/GTIN: 40889942122777, Unit UDI/GTIN: 10889942122776, Lot Number: 22JBF800; q. ARTHROSCOPY PACK - LF, Item Number: DYNJ33193A, Case UDI/GTIN: 40884389363967, Unit UDI/GTIN: 10884389363966, Lot Number: 22IBD173; r. SC ARTHROSCOPY PACK, Item Number: DYNJ34330C, Case UDI/GTIN: 40889942577027, Unit UDI/GTIN: 10889942577026, Lot Number: 22IMD384; s. ARTHROSCOPY PACK-LF, Item Number: DYNJ34797I, Case UDI/GTIN: 40889942451693, Unit UDI/GTIN: 10889942451692, Lot Number: 22IMC421; t. ARTHROSCOPY PACK, Item Number: DYNJ35435C, Case UDI/GTIN: 40888277554697, Unit UDI/GTIN: 10888277554696, Lot Number: 22JBF703; u. ARTHROSCOPY PACK, Item Number: DYNJ35733F, Case UDI/GTIN: 40889942107866, Unit UDI/GTIN: 10889942107865, Lot Number: 22IBN489; v. ARTHROSCOPY PACK, Item Number: DYNJ36624D, Case UDI/GTIN: 40889942540304, Unit UDI/GTIN: 10889942540303, Lot Number: 22JBG374,22IBA906; w. OSC ARTHROSCOPY PK-LF, Item Number: DYNJ37381C, Case UDI/GTIN: 40889942292210, Unit UDI/GTIN: 10889942292219, Lot Number: 22JBY499,22JBB033,22HBY104; x. ARTHROSCOPY PACK, Item Number: DYNJ40334, Case UDI/GTIN: 40884389852737, Unit UDI/GTIN: 10884389852736, Lot Number: 22JBK330; y. ARTHROSCOPY PACK, Item Number: DYNJ42208B, Case UDI/GTIN: 40888277744142, Unit UDI/GTIN: 10888277744141, Lot Number: 22JBP189; z. ARTHROSCOPY PACK, Item Number: DYNJ45173D, Case UDI/GTIN: 40889942485223, Unit UDI/GTIN: 10889942485222, Lot Number: 22JBG783; aa. ARTHROSCOPY PACK, Item Number: DYNJ45340B, Case UDI/GTIN: 40889942120605, Unit UDI/GTIN: 10889942120604, Lot Number: 22IBL202; bb. ARTHROSCOPY PACK, Item Number: DYNJ47103C, Case UDI/GTIN: 40889942489177, Unit UDI/GTIN: 10889942489176, Lot Number: 22JMH577,22IME064; cc. KNEE ARTHROSCOPY PACK, Item Number: DYNJ48572, Case UDI/GTIN: 40888277913890, Unit UDI/GTIN: 10888277913899, Lot Number: 22JBH940; dd. KNEE ARTHROSCOPY PACK, Item Number: DYNJ50120D, Case UDI/GTIN: 40195327195657, Unit UDI/GTIN: 10195327195656, Lot Number: 22JBG571; ee. SHOULDER ARTHROSCOPY PACK, Item Number: DYNJ50126D, Case UDI/GTIN: 40195327212170, Unit UDI/GTIN: 10195327212179, Lot Number: 22JBG572,22IBD245; ff. SHOULDER ARTHROSCOPY, Item Number: DYNJ51381, Case UDI/GTIN: 40889942161325, Unit UDI/GTIN: 10889942161324, Lot Number: 22JBG797; gg. ARTHROSCOPY PACK, Item Number: DYNJ52778A, Case UDI/GTIN: 40889942638117, Unit UDI/GTIN: 10889942638116, Lot Number: 22HMC946; hh. ARTHROSCOPY PACK, Item Number: DYNJ52813, Case UDI/GTIN: 40889942328926, Unit UDI/GTIN: 10889942328925, Lot Number: 22JBD518; ii. ARTHROSCOPY PACK, Item Number: DYNJ56088A, Case UDI/GTIN: 40888277762900, Unit UDI/GTIN: 10888277762909, Lot Number: 22JBW279,22HBR114; jj. ARTHROSCOPY PACK, Item Number: DYNJ57151, Case UDI/GTIN: 40889942721901, Unit UDI/GTIN: 10889942721900, Lot Number: 22JBI446; kk. ARTHROSCOPY PACK, Item Number: DYNJ57741, Case UDI/GTIN: 40889942773672, Unit UDI/GTIN: 10889942773671, Lot Number: 22JBD988; ll. ARTHROSCOPY PACK-LF, Item Number: DYNJ58470, Case UDI/GTIN: 40889942856030, Unit UDI/GTIN: 10889942856039, Lot Number: 22JBT149,22IBU283; mm. ARTHROSCOPY KNEE, Item Number: DYNJ68081B, Case UDI/GTIN: 40195327199853, Unit UDI/GTIN: 10195327199852, Lot Number: 22IBN483; nn. ARTHROSCOPY PACK, Item Number: DYNJ82486, Case UDI/GTIN: 40195327197422, Unit UDI/GTIN: 10195327197421, Lot Number: 22HBT060; oo. HIP ARTHROSCOPY PACK, Item Number: DYNJ82503, Case UDI/GTIN: 40195327197378, Unit UDI/GTIN: 10195327197377, Lot Number: 22HBL505; pp. ARTHROSCOPY PACK, Item Number: DYNJ82546, Case UDI/GTIN: 40195327197927, Unit UDI/GTIN: 10195327197926, Lot Number: 22HBV066; qq. MG NS KNEE ARTHROSCOPY PACK, Item Number: DYNJ82585, Case UDI/GTIN: 40195327198764, Unit UDI/GTIN: 10195327198763, Lot Number: 22IBE887; rr. KNEE ARTHROSCOPY PACK, Item Number: DYNJ82630, Case UDI/GTIN: 40195327199525, Unit UDI/GTIN: 10195327199524, Lot Number: 22JBE442; ss. ARTHROSCOPY PACK, Item Number: DYNJ82707, Case UDI/GTIN: 40195327202317, Unit UDI/GTIN: 10195327202316, Lot Number: 22JMH335,22JMF855; tt. ARTHROSCOPY-LF, Item Number: DYNJ903247B, Case UDI/GTIN: 40889942754664, Unit UDI/GTIN: 10889942754663, Lot Number: 22JBQ059; uu. ARTHROSCOPY KIT, Item Number: DYNJ904304G, Case UDI/GTIN: 40195327209316, Unit UDI/GTIN: 10195327209315, Lot Number: 22JBR652,22IBT829; vv. SHOULDER ARTHROSCOPY, Item Number: DYNJ908907, Case UDI/GTIN: 40195327215577, Unit UDI/GTIN: 10195327215576, Lot Number: 22JBJ375; ww. KNEE ARTHROSCOPY, Item Number: DYNJ908920, Case UDI/GTIN: 40195327215874, Unit UDI/GTIN: 10195327215873, Lot Number: 22JBA830; xx. ARTHROSCOPY PACK, Item Number: DYNJHS0101I, Case UDI/GTIN: 40888277046413, Unit UDI/GTIN: 10888277046412, Lot Number: 22IBK139
Quantity Affected: 1,419 cases (4,349 units)
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-17
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1097-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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