MEDLINE INDUSTRIES, LP - Northfield: 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 Numbe

Hazard

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.

Details from the source

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. Distribution: US Nationwide Distribution Quantity: 3930 units 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),

UPC codes

10193489046465, 20193489046462, 10193489061314, 20193489061311, 10193489063950, 20193489063957, 10193489060904, 20193489060901, 10193489070224, 20193489070221, 10193489044928, 30193489044922, 10193489075458, 20193489075455, 10193489053326, 30193489053320, 10193489045864, 30193489045868, 10193489071498, 30193489071492, 10193489057805, 30193489057809, 10193489072754, 30193489072758, 10193489099843, 30193489099847, 10193489070170, 30193489070174, 10193489071344, 30193489071348, 10193489070231, 30193489070235, 10193489045611, 30193489045615, 10193489048292, 30193489048296, 10193489049817, 30193489049811, 10193489072815, 30193489072819

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.