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Boston Scientific Corporation recalls Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vasc

Recalled July 12, 2017 · FDA recall Z-2645-2017 · Boston Scientific

Hazard
A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user. · FDA Class II
Units
39 boxes of 5 (195 units)
Sold at
CA, FL, KY, MO, NM, OK, OR, PA, and TX.

Description

A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.

Product
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
Manufacturer(s)
Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Boston Scientific Corporation recalls Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vasc | RecallWatchUSA