FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Renal Therapies Group, LLC: Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
- Recall number
- Z-0658-2019
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
- Status
- Terminated
- Initiated
- 2018-11-05
- Posted
- not on file
- Terminated
- 2023-04-17
- Reason
- Potential for external blood leaks from the dialyzer header
- Root cause
- Other
- Action
- On November 6, 2018, Fresenius Medical Care issued URGENT MEDICAL DEVICE RECALL notices to customers. Customers were advised to take the following actions: 1. Check your inventory for the affected lot numbers. 2. If found, discontinue use of these lots. 3. Please all affected units in a secure, segregated area. 4. Contact Stericycle at 1-888-731-7986 for instructions on how to return the recalled product or if replacement product is needed right away. (Refer to EVENT # 6273). 5. Complete and return the Reply Form. Customers with questions may contact Medical Information and Communications at 855-616-2309 or thru the website www.fresenius-medinfo.com.
- Quantity
- 9,097 cs x 12 units each
- Distribution
- US Nationwide
- Lot, serial or model codes
- Lot Numbers: 18HU06016, 18HU06017, 18HU06018 and 18HU06019
- 510(k) numbers
- ["K152367","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