| Class 2 Device Recall Medtronic Custom Perfusion System | |
Date Initiated by Firm | July 17, 2013 |
Date Posted | August 27, 2013 |
Recall Status1 |
Terminated 3 on February 04, 2014 |
Recall Number | Z-2105-2013 |
Recall Event ID |
65831 |
510(K)Number | K891687 |
Product Classification |
Oxygenator, cardiopulmonary bypass - Product Code DTZ
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Product | Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7.
Sterilized by Ethylene Oxide, Do no Reuse.
Product Usage: Usage:
This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. |
Code Information |
Lot: 12096267, 12105099, 12139669, 12166396, 12198322, 12309957, 12416020, 206119223, 206120062, 206180336, 206233199, 206384131, 206496179, 206649807, 206699258, 206758209, 206851971, 206864385, 206919887, 207003072, and 207071455. |
Recalling Firm/ Manufacturer |
Medtronic Inc. Cardiac Rhythm Disease Management 8200 Coral Sea St NE Saint Paul MN 55112-4391
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For Additional Information Contact | 763-526-6000 |
Manufacturer Reason for Recall | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. |
FDA Determined Cause 2 | Process control |
Action | Metronic sent an "Urgent Field Safety Notice" letter dated July, 2013 to all affected customers. The letter described the affected product, problem and actions to be taken by User. Customerss were advised to remove and destroy all affected products. At the same time customers were informed that replacement products can be ordered by contacting their Medtronic representative. Customers were requested to complete the Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612. For any questions they can contact Medtronic Lifeline Technical Services at 877-526-7890 or their Medtronic representative. |
Quantity in Commerce | 217 |
Distribution | Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DTZ
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