Recall Z-0764-2025 ยท FPA Set, Administration, Intravascular
MEDLINE INDUSTRIES, LP - Northfield
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
| Date | Jan 15, 2025 (initiated Dec 16, 2024) |
| Status | Open, Classified |
| 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 delivers three times more fluid per drop than the micro drip chamber. |
| Root cause | Under Investigation by firm |
| Action | An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 12/16/24 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3. Upon receipt of your |
| Quantity | 13,600 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K852140 | NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS) North American Instrument Corp., May 30, 1985 |