FDAFDA · Food and drugs·Recall number Z-1781-2017
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Published April 19, 2017 · Recall initiated: December 13, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- AZ, FL, MO, NJ, NY, OH, PA, and TX.
- Lot
- Lot: 00116127, Expiration Date: September 30, 2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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