Remington MEDICAL Drainage Bag, REF 600-D;
This recall is currently active, issued December 5, 2023. It was issued by Remington Medical Inc..
- Company
- Remington Medical Inc.
- Recall Initiated
- November 3, 2023
- Posted
- December 5, 2023
- Recall Number
- Z-0487-2024
- Quantity
- 3080 devices
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
Distribution
US: PA and FL
Lot / Code Info
UDI/DI 20813079020008, Lot Number 2325111
Root Cause
Labeling mix-ups
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.