Recall Z-1489-2014 ยท DQY Catheter, Percutaneous
Ev3, Inc.
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
| Date | Apr 23, 2014 (initiated Apr 9, 2014) |
| Status | Terminated |
| Reason | Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling. |
| Root cause | Labeling Change Control |
| Action | Consignees were sent a Covidien "Urgent Product Recall" letter dated April 09, 2014. The letter described the problem and the product involved in the recall. The letter described the required actions which included to immediately quarantine and discontinue use of the affected devices and to return affected product. Requested consignees to complete the Verification Form and return it to their Covidien Sales Representative. For questions they can contact Covidien Customer Service at 1-800-716-6000. |
| Quantity | 39 units (31 OUS, 8 US) |
| Distribution | Worldwide Distribution-USA including the states of WV, TX, OK, IN, NY, TX, and NC, and the countries of AUSTRALIA, ISRAEL, TURKEY, UNITED KINGDOM, ITALY, FRANCE, and CHINA. |
| FDA record | Open on fda.gov |