FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
- Recall number
- Z-1173-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
- Status
- Open, Classified
- Initiated
- 2025-01-03
- Posted
- 2025-02-14
- Terminated
- not on file
- Reason
- Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
- Root cause
- Packaging
- Action
- Medline issued an URGENT MEDICAL DEVICE RECALL on 01/03/2025 via email and US Mail, first class. The notice explained the issue, the low probability of clinical risk, and requested the consignee perform the following actions: identify and quarantine all affected product and respond to the notice using the website. Those consignees with affected product will receive labels to affix to the package stating not to use the affected component. All those who further distributed or transferred the product were directed to notify those to whom the product was distributed..
- Quantity
- 36 units
- Distribution
- US: CA
- Lot, serial or model codes
- UDI/DI 10193489736755 (ea) 40193489736756 (cs), Lot Numbers: 22HLA247, 21HLA443, 21JLA520, 22GLA335.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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