Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N
This recall has been terminated (originally issued December 31, 2005).
- Recall Initiated
- November 28, 2005
- Posted
- December 31, 2005
- Terminated
- August 10, 2006
- Recall Number
- Z-0333-06
- Firm Location
- Lexington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR
Distribution
Nationwide
Lot / Code Info
Lot Number: 5LU319
Root Cause
Other
Action Taken
Fresenius Medical notified consignees by letter dated 11/28/05 sent Certified Mail on 11/29/05 requesting return of product inventory.
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