Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,

Summary

The FDA issued a Class I for Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAI by MEDLINE INDUSTRIES, LP - Northfield. Reason: Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber.

Details

Product Description

Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486; 4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, Item Number: 65071193; 5) MTO,NEURO,FLUSH,SPIKE,KIT,BLUE,FLORIDA, Item Number: 600604422; 6) MTO,NEURO,KIT,-,JERSEY,SHORE PG, Item Number: 60100045; 7) MTO,RADIOLOGY,KIT,HAMOT MED CEN, Item Number: 650801715; 8) MTS,135,CDS,IV,TUBE-JEFFERSON UNIV., Item Number: 60232481; 9) MTS,135,YELLOW,MICRO,SPIKE,LUTHERAN MED, Item Number: 60120583; 10) MTS,ANGIO,NEURO,KIT,NORTH SHORE UNIV, Item Number: 601403920; 11) MTS,CUST. FILTER-NEWYORK UNIVERSITY, Item Number: 62140602; 12) MTS,INTERV,NEURO,KIT-WESTCHESTER,MC, Item Number: 602301614; 13) MTS,NEU,NORTH SHORE HOSPITAL, Item Number: 6010771601; 14) MTS,NEURO,KIT, Item Number: 600602914; 15) MTS,NEURO,KIT,2,NEWENGLAND MED CTR, Item Number: 601400111; 16) MTS,NEURO,KIT,YLW&RED,FLORIDA HOSP, Item Number: 600604423; 17) MTS,NEURO,KIT-JOHN,F,KENNEDY MED CENTER, Item Number: 60110552; 18) MTS,NEURO,KIT-OVERLOOK HOSPITAL PG, Item Number: 60150035; 19) MTS,NEURO,SPIKE,KIT,CAPITAL HLTHSYS-FULD, Item Number: 60182723; 20) MTS,NEURO-RADIOLOGY,KIT-YALE-NEWHAVEN, Item Number: 602500214; 21) MTS,STROKE/EMBO,KIT,NORTH SHORE UNIV, Item Number: 601403921; 22) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601305210; 23) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601400110;

Lot/Code Info: 1) 60130527 UDI-D:10193489046465(each), 20193489046462(case), Lot Number:0000133032; 2) 65111341 UDI-D:10193489061314(each), 20193489061311(case), Lot Number:0000129541; 3) 65111341 UDI-D:10193489061314(each), 20193489061311(case), Lot Number:0000134701; 4) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000129544; 5) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000128715; 6) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000133060; 7) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000131657; 8) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000135723; 9) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000135294; 10) 65071193 UDI-D:10193489060904(each), 20193489060901(case), Lot Number:0000130171; 11) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000135606; 12) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000134729; 13) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000137115; 14) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000130833; 15) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000131669; 16) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000129513; 17) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000128721; 18) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000129523; 19) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000132393; 20) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000134940; 21) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000144158; 22) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000139082; 23) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000130138; 24) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000132350; 25) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000135736; 26) 60232481 UDI-D:10193489053326(each), 30193489053320(case), Lot Number:0000129534; 27) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000133660; 28) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000136501; 29) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000131600; 30) 601403920 UDI-D:10193489071498(each), 30193489071492(case), Lot Number:0000131376; 31) 601403920 UDI-D:10193489071498(each), 30193489071492(case), Lot Number:0000130940; 32) 62140602 UDI-D:10193489057805(each), 30193489057809(case), Lot Number:0000132222; 33) 62140602 UDI-D:10193489057805(each), 30193489057809(case), Lot Number:0000141215; 34) 602301614 UDI-D:10193489072754(each), 30193489072758(case), Lot Number:0000133659; 35) 6010771601 UDI-D:10193489099843(each), 30193489099847(case), Lot Number:0000127859; 36) 600602914 UDI-D:10193489070170(each), 30193489070174(case), Lot Number:0000135717; 37) 600602914 UDI-D:10193489070170(each), 30193489070174(case), Lot Number:0000128447; 38) 601400111 UDI-D:10193489071344(each), 30193489071348(case), Lot Number:0000133121; 39) 601400111 UDI-D:10193489071344(each), 30193489071348(case), Lot Number:0000130573; 40) 600604423 UDI-D:10193489070231(each), 30193489070235(case), Lot Number:0000128607; 41) 600604423 UDI-D:10193489070231(each), 30193489070235(case), Lot Number:0000137751; 42) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000131878; 43) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000130577; 44) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000138084; 45) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000130187; 46) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000131883; 47) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000143095; 48) 60182723 UDI-D:10193489049817(each), 30193489049811(case), Lot Number:0000130988; 49) 602500214 UDI-D:10193489072815(each), 30193489072819(case), Lot Number:0000127874; 50) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000131619; 51) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000133025; 52) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000136559; 53) 601305210 UDI-D:10193489070989(each), 30193489070983(case), Lot Number:0000130984; 54) 601400110 UDI-D:10193489071337(each), 30193489071331(case), Lot Number:0000128757;

Quantity Affected: 3930 units

Reason for Recall

Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-12-16

Company