Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
FDA Recall Z-1324-2016 · Posted 2016-04-05
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Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusTerminated
Product CodeFJI
Date Initiated2016-02-26
Date Terminated2017-06-26
Product Quantity1,650 units
Reason for Recall
Dialyzer header leak due to possible improper torque
Firm 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: [email protected] 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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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