Remington MEDICAL Drainage Bag, REF 600-D;
FDA device recall Z-0487-2024 · posted 2023-12-05 · Open, Classified
Recall details
- Recalling firm
- Remington Medical, Inc.
- Reason for recall
- There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Open, Classified
- Product code
- EXF
- Quantity affected
- 3080 devices
- Distribution
- US: PA and FL
- Date initiated
- 2023-11-03
- Date posted
- 2023-12-05
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRAINAGE BAG (K990428) | Remington Medical, Inc. | 1999-08-12 |