Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
FDA device recall Z-1324-2016 · posted 2016-04-05 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Reason for recall
- Dialyzer header leak due to possible improper torque
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FJI
- Quantity affected
- 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.
- Date initiated
- 2016-02-26
- Date posted
- 2016-04-05
- Date terminated
- 2017-06-26
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS HEMOFLOW F3, F4, F5, F7 (K874872) | Seratronics, Inc. | 1988-02-19 |