Recall Z-1807-2024 ยท FPA Set, Administration, Intravascular
MEDLINE INDUSTRIES, LP - Northfield
Namic FLUID DELIVERY SET, REF 91300040
| Date | May 10, 2024 (initiated Mar 12, 2024) |
| Status | Open, Classified |
| Reason | Products have a lack of sterility assurance. |
| Root cause | Process control |
| Action | Medline issued a Medical Device Recall notice to its consignees on 03/12/2024 via email and US Mail. The notice explained the issue, potential risk, and requested destruction of the affected product. Those who further distributed the product were directed to notify those to whom they shipped the product. |
| Quantity | 50 units |
| Distribution | US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX. |
| 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 |