medical Class I Updated 2025-01-22

MEDLINE INDUSTRIES, LP - Northfield recalls Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,

Recalled Product

Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221; 5) FDS,135,NV,MICRO-CHAMBER,W/FILTER,YELLOW, Item Number 949000223

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 1)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000128741; 2)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000134505; 3)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000133893; 4)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000135769; 5)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000139596; 6)949000222UDI-D:10197344018550(each)30197344018554(case), Lot Number:0000133018; 7)949000224UDI-D:10197344018642(each)30197344018646(case), Lot Number:0000136573; 8)949000221UDI-D:10197344018567(each)30197344018561(case), Lot Number:0000133036; 9)949000223UDI-D:10197344018543(each)30197344018547(case), Lot Number:0000133031;

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