Recall Z-0534-2024 ยท FAQ Bag, Urine Collection, Leg, For External Use, Sterile
MEDLINE INDUSTRIES, LP - Northfield
Medline Leg bag, REF DYND12578
| Date | Sep 30, 2024 (initiated Oct 19, 2023) |
| Status | Open, Classified |
| Reason | Undeclared latex |
| Root cause | Labeling mix-ups |
| Action | Medline issued a recall notice to its consignees on 10/16/2023 by USPS First Class Mail. The notice explained the issue, potential risk user, and requested destruction of the affected product at the consignee. Anyone who further distributed the product is directed to notify those to whom the product was distributed. |
| Quantity | 19406 devices |
| Distribution | US and Panama |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.