Fresenius Medical Care North America Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N
Brand
Fresenius Medical Care North America
Lot Codes / Batch Numbers
Lot Number: 5LU319
Products Sold
Lot Number: 5LU319
Fresenius Medical Care North America is recalling Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N due to Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR
Recommended Action
Per FDA guidance
Fresenius Medical notified consignees by letter dated 11/28/05 sent Certified Mail on 11/29/05 requesting return of product inventory.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026