Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99...
FDA Recall #Z-0764-2025 — Class I — December 16, 2024
Product Description
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
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.
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
13,600 units
Distribution
US Nationwide Distribution
Code Information
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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated