Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by E
FDA device recall Z-2105-2013 · posted 2013-08-27 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 217
- Distribution
- Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
- Date initiated
- 2013-07-17
- Date posted
- 2013-08-27
- Date terminated
- 2014-02-04
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE (K891687) | Medtronic Blood Systems, Inc. | 1989-05-31 |