Recall Z-0801-2025
Fresenius Medical Care Holdings, Inc. · initiated December 5, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dialyzer Optiflux 160NRe
Codes / lots: UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.
Reason for recall
Potential for internal blood leaks due to cracked polyurethane
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0801-2025
- Initiated
- December 5, 2024
- Posted by FDA
- January 3, 2025
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Quantity
- 5,351 cases (64,212 dialyzers)
- Distribution
- Nationwide Distribution.
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA