Recalls / —
—#151920
Product
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
- FDA product code
- DQO — Catheter, Intravascular, Diagnostic
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K121694
- Affected lot / code info
- Lot: 00116127, Expiration Date: September 30, 2018
Why it was recalled
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 (FDA determination)
Employee error
Action the firm took
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
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 2 Scimed Pl, Maple Grove, Minnesota 55311-1565
Distribution
- Distribution pattern
- AZ, FL, MO, NJ, NY, OH, PA, and TX.
Timeline
- Recall initiated
- 2016-12-13
- Posted by FDA
- 2017-03-23
- Terminated
- 2017-11-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #151920. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.