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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius

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  Class 2 Device Recall Fresenius see related information
Date Initiated by Firm February 26, 2016
Date Posted April 05, 2016
Recall Status1 Terminated 3 on June 26, 2017
Recall Number Z-1324-2016
Recall Event ID 73387
510(K)Number K874872  
Product Classification Dialyzer, capillary, hollow fiber - Product Code FJI
Product Fresenius Hemoflow F3 Dialyzer
Part Number: 0520165A

Indicated for Acute and Chronic Hemodialysis
Code Information Lot Number: 15KU04011 Exp. Date : 08/31/2013
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
781-699-9000
Manufacturer Reason
for Recall		 Dialyzer header leak due to possible improper torque
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FJI and Original Applicant = SERATRONICS, INC.
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