Device product
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Z-1781-2017
Product summary
- Event
- Event 76002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 boxes of 5 (130 singles)
- Official record key
device-enforcement:Z-1781-2017
Official wording
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.
Code information: Lot: 00116127, Expiration Date: September 30, 2018
Distribution pattern: AZ, FL, MO, NJ, NY, OH, PA, and TX.
Derived failure modes
-
Labeling or packaging
mislabeling