FDA Medical Device Recalls (openFDA)
Fresenius Medical Care North America: Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N
- Recall number
- Z-0334-06
- Recalling firm
- Fresenius Medical Care North America
- Product
- Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N
- Status
- Terminated
- Initiated
- 2005-11-28
- Posted
- 2005-12-31
- Terminated
- 2006-08-10
- Reason
- Mislabeled: Inner product mislabeled as 180NR (Catalog Number 0500318N) instead of 160NR
- Root cause
- Other
- Action
- Fresenius Medical notified consignees by letter dated 11/28/05 sent Certified Mail on 11/29/05 requesting return of product inventory.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number: 5LU319
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3001451489
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28