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U.S. Department of Health and Human Services

Class 2 Device Recall Medrad

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 Class 2 Device Recall Medrad see related information
Date Posted May 30, 2014
Recall Status1 Terminated on April 16, 2015
Recall Number Z-1673-2014
Recall Event ID 68293
510(K)Number K073051 
Product Classification Pump, Infusion - Product Code FRN
Product Medrad Continuum MR Infusion system- non-wireless system

The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
Code Information 3
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Recalling Firm/
Manufacturer
Bayer Corp
100 Global View Dr
Warrendale PA 15086-7601
724-940-6910
For Additional Information Contact Customer Support
724-940-6910
Manufacturer Reason
for Recall
There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.
FDA Determined
Cause 2
Component design/selection
Action Bayer sent an Urgent Medical Device Recall and Removal Letters dated April 3, 2014, and April 30, 2014, were sent to direct accounts to notify them of the bracket issue and to provide additional instructions for testing and/or returning the brackets. As a critical medical needs site currently using Continuum with a recalled bracket you have two options: 1. Immediately return your Continuum(s) for refund. 2. Take actions to ensure continued safe use of your system associated with the bracket recall. You will still be eligible for a refund when you return the system no later than June 30, 2015. When you are ready to return your Continuum(s), please refer to: ¿ Enclosure 2: Disassembly Instructions. ¿ Enclosure 3: Continuum Return Form. We sincerely regret the inconvenience and impact of the recalls and subsequent removal of Continuum from the market. Should you have questions regarding the pro-rated refund program, please call 877-229-3767.
Quantity in Commerce 1347
Distribution Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = MEDRAD, INC.
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