Recall Z-1023-2016 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures
| Date | Feb 26, 2016 (initiated Feb 4, 2016) |
| Status | Terminated |
| Reason | Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. |
| Root cause | Component design/selection |
| Action | Medtronic sent an Urgent Medical Device Safety Alert dated February 2016 to all consignees on February 4, 2016. The letter described the problem and the product involved in the recall. Advised consignees to review the Terumo CVS Urgent Safety Alert and follow the instructions in the Recommended Action Section of the Urgent Safety Alert letter. Requested consignees to completed the Customer Confirmation Certificate and Email completed form(s) to RS.CFQFCA@Medtronic.com. If email is not available, fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. For questions co |
| Quantity | 9890 (7773 US, 2117 OUS) |
| Distribution | Worldwide Distribution - US including US: AK, AZ, CA, DE, FL, HI, IL, LA, MD. MA. MN, MS, MO, NE, NJ,. NHY, NC, ND, OH, OR, PAM TN, TX, VA, WA, WV, and WI. Internationally to Australia, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, France, Germany, Israel, Japan, Netherlands, Serbia |
| FDA record | Open on fda.gov |