Recall Z-0813-2016 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Sorin Group USA, Inc.
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.
| Date | Feb 16, 2016 (initiated Jan 25, 2016) |
| Status | Terminated |
| Reason | Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case. |
| Root cause | Employee error |
| Action | LivaNova sent an Urgent Safety Alert dated January 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advice on action to be taken: "Remove and discard the IFU included within the case packaging for the product. "A copy of the correct IFU (Part Number 435085202, Revision B) is attached with this letter "Print copies of the IFU and place with the product. For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday BAM to 5PM MT) or e-mail USFieldSafetyActions@livan |
| Quantity | 60 |
| Distribution | US Distribution to CA., and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943934 | AORTIC ARCH CANNULAS Sorin Group Italia S.R.L., Jun 2, 1995 |