Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB341...
FDA Recall #Z-0964-2017 — Class II — December 6, 2016
Product Description
Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables either interface an EP catheter with the appropriate external stimulation or recording equipment or, serve as an extension cable between an EP catheter and equipment out of immediate reach
Reason for Recall
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Recalling Firm
Stryker Sustainability Solutions — Tempe, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
U.S. distribution to the following: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, WA, CT Foreign distribution to the following: CA.
Code Information
All lots with the following Expiration Date Scope: Between 3/1/2018 and 10/31/2018 (Also displayed as Mar-2018 to Oct-2018)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated