Recall Z-1781-2017 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Corporation
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
| Date | Mar 23, 2017 (initiated Dec 13, 2016) |
| Status | Terminated |
| Reason | One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters. |
| Root cause | Employee error |
| Action | Customers were sent an Urgent Medical Device Removal letter, dated 12/5/2016, via overnight mail delivery beginning 12/15/2016. The letter identified affected product, described the issue, and asked for product to be returned. Removal instructions were provided and a Reply Verification Tracking Form was asked to be returned. Questions can be directed to Nicole Pshon, Field Action Manager at 763-494-1133 or BSCFieldActionCenter@bsci.com |
| Quantity | 26 boxes of 5 (130 singles) |
| Distribution | AZ, FL, MO, NJ, NY, OH, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121694 | IMAGER II ANGIOGRAPHIC CATHETER Boston Scientific Corp, Sep 14, 2012 |