Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner
FDA device recall Z-1781-2017 · posted 2017-03-23 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 26 boxes of 5 (130 singles)
- Distribution
- AZ, FL, MO, NJ, NY, OH, PA, and TX.
- Date initiated
- 2016-12-13
- Date posted
- 2017-03-23
- Date terminated
- 2017-11-22
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMAGER II ANGIOGRAPHIC CATHETER (K121694) | Boston Scientific Corp | 2012-09-14 |