Device product
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.
Z-0963-2017
Product summary
- Event
- Event 75941
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0963-2017
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.