Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to sel...
FDA Recall #Z-2645-2017 — Class II — December 15, 2016
Product Description
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)
Reason for Recall
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.
Recalling Firm
Boston Scientific Corporation — Maple Grove, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
39 boxes of 5 (195 units)
Distribution
CA, FL, KY, MO, NM, OK, OR, PA, and TX.
Code Information
Lot: 00112758, Use by 2018-05-11
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated