Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M00131...
FDA Recall #Z-1781-2017 — Class II — December 13, 2016
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.
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
26 boxes of 5 (130 singles)
Distribution
AZ, FL, MO, NJ, NY, OH, PA, and TX.
Code Information
Lot: 00116127, Expiration Date: September 30, 2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated