Recall Z-0040-06 ยท LNM Agent, Bulking, Injectable For Gastro-Urology Use
Boston Scientific Corporation
Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS
| Date | Oct 28, 2005 (initiated Sep 23, 2005) |
| Status | Terminated |
| Reason | Incorrect implantation may cause serious health complications |
| Root cause | Other |
| Action | Boston Scientific issued Recall notification by FED'X on 9/23/05 as follows Customers/ Hospital Account / Distributors: A Recall Notification Package will be sent to the risk manager of each hospital account via FedEx. This package contains a Recall Notification Letter, instructions on how to return product, a Recall Verification Form, and a Physician Letter that provides recommendations of patient follow-up. . Physicians Trained in the Enteryx Procedure: All physicians that attended the physician training program sent, via FedEx, a Physician Letter notifying them of the voluntary recall |
| Quantity | M00572600 =7844 kits ;M00572500=859 kits |
| Distribution | Nationwide : |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042882 | ENTERYX INJECTION CATHETER Boston Scientific Corp, Nov 9, 2004 |