Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N
FDA device recall Z-0334-06 · posted 2005-12-31 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care North America
- Reason for recall
- Mislabeled: Inner product mislabeled as 180NR (Catalog Number 0500318N) instead of 160NR
- Action taken
- Fresenius Medical notified consignees by letter dated 11/28/05 sent Certified Mail on 11/29/05 requesting return of product inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDI
- Distribution
- Nationwide
- Date initiated
- 2005-11-28
- Date posted
- 2005-12-31
- Date terminated
- 2006-08-10
- Location
- Lexington, MA
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