Recall Z-2871-2017 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Sorin Group USA, Inc.
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
| Date | Jun 9, 2017 |
| Status | Terminated |
| Reason | Identification of excess plastic on the tip of the cannula. |
| Root cause | Process control |
| Action | LivaNova sent an Urgent Medical Device letter dated June 16, 2017 to affected customers via certified mail or e-mail. The letter identified the affected product, problem and actions to be taken. The notice instructs customers to remove all recalled product from inventory and contact LivaNova Customer Support at 800-650-2623 to arrange for product return and replacement. |
| Quantity | 105,770 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of : AR, AZ, CA, GA, IL, IN, KS, MI, MN, MO, NC, NE, NY, OK, PA, SD, TX, & VA. and foreign countries of: Canada, Iran, Mexico, & New Zealand. |
| 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 |