FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Dialyzer Optiflux 160NRe
- Recall number
- Z-0801-2025
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Dialyzer Optiflux 160NRe
- Status
- Open, Classified
- Initiated
- 2024-12-05
- Posted
- 2025-01-03
- Terminated
- not on file
- Reason
- Potential for internal blood leaks due to cracked polyurethane
- Root cause
- Process control
- Action
- Fresenius Medical Care notified consignees on about 12/05/2024 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to stock immediately for either of the affected lot numbers, immediately discontinue use of Optiflux F160NRe Dialyzer(s) with lot codes, place any of the affected units in a secure, segregated area, arrange for return of affected product and complete and return the provided Reply Form. Additionally, consignees were instructed to forward the notification to any personnel within the organization or to customers where product was further distributed.
- Quantity
- 5,351 cases (64,212 dialyzers)
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.
- 510(k) numbers
- ["K162488"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- 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