Recall Z-1324-2016
Fresenius Medical Care Renal Therapies Group, LLC · initiated February 26, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Codes / lots: Lot Number: 15KU04011 Exp. Date : 08/31/2013
Reason for recall
Dialyzer header leak due to possible improper torque
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1324-2016
- Initiated
- February 26, 2016
- Posted by FDA
- April 5, 2016
- Terminated
- June 26, 2017
- Product code
- FJI – Dialyzer, Capillary, Hollow Fiber
- 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.
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA