Dialyzer Optiflux 160NRe
- Recall Initiated
- December 5, 2024
- Posted
- January 3, 2025
- Recall Number
- Z-0801-2025
- Quantity
- 5,351 cases (64,212 dialyzers)
- Firm Location
- Waltham, MA
Reason for Recall
Potential for internal blood leaks due to cracked polyurethane
Distribution
Nationwide Distribution.
Lot / Code Info
UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.
Root 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.