Recall Z-2105-2013— Medtronic Inc. Cardiac Rhythm Disease Management
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2013-07-17, terminated 2014-02-04. It names one FDA 510(k) clearance: K891687. 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.. Reason: 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..
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-17
- Terminated
- 2014-02-04
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.