FDA Medical Device Recalls (openFDA)
Remington Medical, Inc.: Remington MEDICAL Drainage Bag, REF 600-D;
- Recall number
- Z-0487-2024
- Recalling firm
- Remington Medical, Inc.
- Product
- Remington MEDICAL Drainage Bag, REF 600-D;
- Status
- Open, Classified
- Initiated
- 2023-11-03
- Posted
- 2023-12-05
- Terminated
- not on file
- 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
- Lot, serial or model codes
- UDI/DI 20813079020008, Lot Number 2325111
- 510(k) numbers
- ["K990428"]
- PMA numbers
- not on file
- Product code
- EXF
- Firm FEI
- 1000132370
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28