Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-2105-2013

Z-2105-2013 Class II Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
September 4, 2013
Initiation Date
July 17, 2013
Termination Date
February 4, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
217

Product Description

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.

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.

Distribution Pattern

Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA

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.

Other recalls by Medtronic Inc. Cardiac Rhythm Disease Management

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  • Z-1356-2015 Class II — Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Us (March 17, 2015)
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  • Z-1661-2014 Class II — Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generat (April 29, 2014)
  • Z-0999-2014 Class II — Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB787 (January 30, 2014)
  • Z-0995-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (January 30, 2014)
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  • Z-0997-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vent (January 30, 2014)