| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00335-1 |
| Product Name/Description |
Teleflex Medical CAPIO Sutures
Catalog Numbers: 833-114, 833-123, 833-124, 833-136, 833-137, 833-213
Lot Numbers: Multiple
ARTG Numbers: 179742 and 164364 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific has been notified by Teleflex Medical that certain lots of their products did not meet minimum needle attachment strength, knot tensile strength, minimum diameter, or minimum resorption strength requirements. This may result in suture breakage, delay in procedure, wound dehiscence, or the need for additional surgical intervention. |
| Recall Action |
Recall |
| Recall Action Instructions |
Boston Scientific is recalling affected lots of Capio sutures. Distributors are requested to forward the recall letter on to their customers. |
| Contact Information |
02 8063 8146 - Boston Scientific Quality Administrator |