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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 May 24, 2013
Date Posted July 11, 2013
Recall Status1 Terminated 3 on October 07, 2019
Recall Number Z-1693-2013
Recall Event ID 65090
510(K)Number K080964  K093902  K101715  K111639  K113427  K120505  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Fresenius Service Replacement 0-Ring.

Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T

Code Information Part Number: 640919
Recalling Firm/
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
FDA Determined
Cause 2
Nonconforming Material/Component
Action Fresenius notified customers on May 24, 2013, by telephone and by certified mail with signature confirmation and fax-back form. Customers were instructed to examine their stock immediately to determine whether they have any of the affected parts on hand. If customers have the affected parts, they will be instructed to immediately discontinue use and place all 0-rings in a secure area for return to Fresenius Medical Care North America. Please contact your Fresenius Medical Care Technical Service Team at 1-800-227-2572, (choose option 4, then option 2) for instructions how to return the recalled product.
Quantity in Commerce 725 units
Distribution Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.
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 = KDI and Original Applicant = FRESENIUS MEDICAL CARE
510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE