Recall Z-0487-2024 ยท EXF Bag, Bile Collecting
Remington Medical, Inc.
Remington MEDICAL Drainage Bag, REF 600-D;
| Date | Dec 5, 2023 (initiated Nov 3, 2023) |
| Status | Open, Classified |
| Reason | There is an error with the "Use by Date" and "Date of Manufacturer" on the box label. |
| Root cause | Labeling mix-ups |
| Action | Remington Medical issued an URGENT: RECALL NOTIFICATION LETTER to its consignees on 11/03/2023 via email. The notice explained the issue, the potential risk, and requested the notice be communicated to all parties to whom it was distributed. If allowed by the consignee's internal procedures, remove the pouches from the box, as the pouch label correctly identifies the actual Date of Manufacture date and Use By date. The firm will replace the affected devices. |
| Quantity | 3080 devices |
| Distribution | US: PA and FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990428 | DRAINAGE BAG Remington Medical, Inc., Aug 12, 1999 |