FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
- Recall number
- Z-1339-2012
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
- Status
- Terminated
- Initiated
- 2012-03-06
- Posted
- 2012-03-30
- Terminated
- 2016-08-08
- Reason
- Risk of internal blood leaks affecting the hemodialyzers.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 30,576 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Number 11PU01012 Exp Date: 11/2014
- 510(k) numbers
- ["K003498"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3001451489
- Firm city
- Waltham
- 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