Boston Scientific Imager II Angiographic Catheter recalled over labeling errors

Recall date

December 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Boston Scientific Corporation recalls Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inne…

Recall number

Z-1781-2017

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

AZ, FL, MO, NJ, NY, OH, PA, and TX.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)