Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cabl...
FDA Recall #Z-0963-2017 — Class II — December 6, 2016
Product Description
Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects to the appropriate equipment. The cables either interface an ablation catheter with the appropriate external radiofrequency generator or, serve as an extension cable between an ablation 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