Recall Z-2645-2017 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Corporation
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
| Date | Jun 27, 2017 (initiated Dec 15, 2016) |
| Status | Terminated |
| Reason | A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user. |
| Root cause | Employee error |
| Action | Customers were sent an Urgent Medical Device Removal letter, dated 12/15/2016, 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 | 39 boxes of 5 (195 units) |
| Distribution | CA, FL, KY, MO, NM, OK, OR, 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 |