Z-0964-2017 Class II Terminated
FDA device recall Z-0964-2017 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 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.
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-0964-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026