Device product
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
Z-0964-2017
Product summary
- Event
- Event 75941
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0964-2017
Official wording
Reason: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
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)
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.
Derived failure modes
-
Unknown
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.