FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
- Recall number
- Z-1303-2022
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
- Status
- Terminated
- Initiated
- 2022-05-04
- Posted
- not on file
- Terminated
- 2024-05-06
- Reason
- Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
- Root cause
- Under Investigation by firm
- Action
- A Customer Notification was sent to the five (5) affected consignees on 05/04/2022 via USPS First Class Mail. The firm also followed up with phone calls with consignees with instructions to examine their stock to determine whether they have affected product on hand, and to remove product from their inventory.
- Quantity
- 19 cases
- Distribution
- US Nationwide distribution in the state of Pennsylvania.
- Lot, serial or model codes
- UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017
- 510(k) numbers
- ["K162488"]
- 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