Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone. Intended
FDA device recall Z-1622-2011 · posted 2011-03-22 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- There is an increased risk of an internal blood leak.
- Action taken
- FMCNA notified consignees on 2/16/11 by telephone and follow-up with an Urgent FMCNA Optiflux F250NRe Recall letter via Certified Mail, return Receipt requested. The firm states in the letter that there is an increased risk of an internal blood leak affecting a small percentage of the two lots of dialyzers. They are asking customers to examine their inventory, to discontinue use, and segregate the affected product in a secure place. Customers are to contact their FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return product. Used dialyzers should not be returned. If there are any questions, Customer Service should be contacted.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 38,364 units
- Distribution
- Worldwide Distribution -- USA and Canada.
- Date initiated
- 2011-02-16
- Date posted
- 2011-03-22
- Date terminated
- 2013-02-12
- Location
- Waltham, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIFLUX F250NR, MODEL 0500325E (K082414) | Fresenius Medical Care North America | 2008-10-28 |