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U.S. Department of Health and Human Services

Class 2 Device Recall Medrad(R) Continuum MR Infusion System Standard Administration Kit

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 Class 2 Recall
Medrad(R) Continuum MR Infusion System Standard Administration Kit
see related information
Date Posted December 20, 2012
Recall Status1 Open
Recall Number Z-0596-2013
Recall Event ID 61734
Premarket Notification
510(K) Number
K051499 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System 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.
Code Information Catalog number - Standard Kit: MIK 200A. See firm's website - www.medrad.com for specific serial and lot numbers.
Recalling Firm/
Manufacturer
Medrad Inc
1 Medrad Dr
Indianola, Pennsylvania 15051-9759
For Additional Information Contact Kristi Carrico
412-767-2400
Manufacturer Reason
for Recall
Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Bayer HealthCare, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 17, 2012 via the USPS certified mail to its consignees/customers. The firm expanded the recall on May 11, 2012 and sent a second letter entitled "EXPANDED URGENT MEDICAL DEVICE RECALL" to its affected consignees/customers notifying them of the additional issue. The letters described the product, problem and actions to be taken. The customers were instructed to return pump now; contact customer support at 1-877-229-3767 for a return goods authorization (RGA); complete and return Response Form, include RGA numbers, via Fax to Bayer Compliance at 412-4060942, and/or wait to return the pump when they begin contacting customers with this subset of pumps in August to make arrangements for a replacement pump. If you have questions, please contact our customer support team at 1-877-229-3767 or visit www.medrad.com for more information.
Quantity in Commerce 1,229 Pumps total
Distribution Worldwide distribution: USA (nationwide) and countries of: Australia, Bermuda, Brazil, Canada, China, Chile, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Guam, Hong Kong, India, Israel, Italy, Japan, Korea, Lebanon, Mexico, Malaysia, Netherland, Poland, Portugal, Puerto Rico, Sweden, Singapore, Taiwan, Thailand, and Venezula.
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 = FPA and Original Applicant = MEDEGEN MEDICAL MANUFACTURING SERVICES
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