FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Renal Therapies Group, LLC: Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
- Recall number
- Z-1324-2016
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
- Status
- Terminated
- Initiated
- 2016-02-26
- Posted
- 2016-04-05
- Terminated
- 2017-06-26
- Reason
- Dialyzer header leak due to possible improper torque
- Root cause
- Process control
- Action
- The firm, Fresenius Medical Care Renal Therapies Group, LLC issued an "URGENT MEDICAL DEVICE RECALL" letter dated 2/24/16 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of your Hemoflow F3 Dialyzer; place all affected units in a secure, segregated area; contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product, and fill out and return the attached Reply Form via fax to: 781-699-9796 ATTN: Quality Department or scan and email to: NOTIFYRA@fmc-na.com at your earliest convenience. If you have any additional medical concerns or questions, please contact Medical Information and Communication at 855-616-2309 or Website: www.fresenius-medinfo.com.
- Quantity
- 1,650 units
- Distribution
- US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA.
- Lot, serial or model codes
- Lot Number: 15KU04011 Exp. Date : 08/31/2013
- 510(k) numbers
- ["K874872"]
- PMA numbers
- not on file
- Product code
- FJI
- 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