• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

  • Print
  • Share
  • E-mail

Event Detail

Event ID 65090
Product Type Devices
Status Ongoing
Recalling Firm Fresenius Medical Care Holdings, Inc.
City Waltham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-24
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Part Number: 640919 Class II Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber) 725 units Z-1693-2013