Recall Z-1324-2016 ยท FJI Dialyzer, Capillary, Hollow Fiber
Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
| Date | Apr 5, 2016 (initiated Feb 26, 2016) |
| Status | Terminated |
| 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: NOTIF |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874872 | FRESENIUS HEMOFLOW F3, F4, F5, F7 Seratronics, Inc., Feb 19, 1988 |