Z-1781-2017 Class II Terminated
FDA device recall Z-1781-2017 was initiated by Boston Scientific Corporation on Dec 13, 2016 and is designated Class II. 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… The recall status is terminated (terminated Nov 22, 2017). Affected quantity: 26 boxes of 5 (130 singles).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 19, 2017
- Initiation Date
- Dec 13, 2016
- Termination Date
- Nov 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 boxes of 5 (130 singles)
Product Description
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
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.
Distribution Pattern
AZ, FL, MO, NJ, NY, OH, PA, and TX.
Code Information
Lot: 00116127, Expiration Date: September 30, 2018
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1781-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026