Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute or chronic renal failu
FDA device recall Z-1339-2012 · posted 2012-03-30 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Risk of internal blood leaks affecting the hemodialyzers.
- Action taken
- Fresenius North America notified consignees on 3/6/12 by recall notification letter titled:Urgent FMCNA Optiflux F160NRe Hemodialyzer Recall, by certified mail with return receipt. The letter identified the affected product and described the reason for the recall. Customers were instructed to examine their stock immediately to determine whether they have any of the affected lot on hand. If customers have the affected lot, they have been instructed to immediately discontinue use and place all unused units in a secure area for return to Fresenius Medical Care North America. A Reply Response from is to be completed and returned. Customers have been instructed to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. Contact 1-800-323-5188.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 30,576 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2012-03-06
- Date posted
- 2012-03-30
- Date terminated
- 2016-08-08
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS OPTIFLUX 200A (K003498) | Fresenius Medical Care North America | 2001-01-04 |