Remington MEDICAL Drainage Bag, REF 600-D recallZ-0487-2024 · Remington Medical, Inc. · initiated Nov 3, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remington Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-0487-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 3, 2023
- Posted by the FDA
- Dec 5, 2023
- Recalling firm
- Remington Medical, Inc.
- Quantity
- 3080 devices
- Product code
- EXF
- FDA submissions
- K990428
- Distribution
- US: PA and FL
Product description
Remington MEDICAL Drainage Bag, REF 600-D;
Code information (models, lots, serial numbers)
UDI/DI 20813079020008, Lot Number 2325111
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Drainage Bag 600-DRemington Medical, Inc. · BAG, BILE COLLECTING1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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