Z-0487-2024Class II
Remington MEDICAL Drainage Bag, REF 600-D
Remington Medical / initiated 2023-11-03 / Open, Classified / root cause: labeling and UDI
Remington Medical, Inc. began a recall of Remington MEDICAL Drainage Bag, REF 600-D on . FDA classified it as Class II and gives the reason as "There is an error with the "Use by Date" and "Date of Manufacturer" on the box label". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0487-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Remington Medical
- Product
- Remington MEDICAL Drainage Bag, REF 600-D;
- Product code
- EXF Bag, Bile Collecting
- Reason for recall
- There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
- Root cause tag
- labeling and UDI
- FDA 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 in commerce
- 3080 devices
- Distribution
- US: PA and FL
- Product codes and lots
- UDI/DI 20813079020008, Lot Number 2325111
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0487-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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