Recall Z-2757-2016 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Sorin Group USA, Inc.
Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded
| Date | Sep 8, 2016 (initiated Aug 12, 2016) |
| Status | Terminated |
| Reason | The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement. |
| Root cause | Process control |
| Action | LivaNova issued an Urgent Safety Alert letter via certified mail on August 12, 2016 to all affected customers. The letter instructed customers to check their inventory to determine if the Cannulae belongs to the product code and lots listed. If the customer does not have any of the products described in the communication, please complete the response form below and return it per the instructions indicated on the form; otherwise, please check the tip angle to determine if it is conforming to specifications. If specification is not met, please file a complaint through your normal process whethe |
| Quantity | 1205 units worldwide |
| Distribution | Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy. |
| FDA record | Open on fda.gov |