Z-0963-2017 Class II Terminated
FDA device recall Z-0963-2017 was initiated by Stryker Sustainability Solutions on Dec 6, 2016 and is designated Class II. Reason for recall: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. The recall status is terminated (terminated Jun 8, 2017).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 18, 2017
- Initiation Date
- Dec 6, 2016
- Termination Date
- Jun 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
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.
Distribution Pattern
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0963-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026