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Stryker Sustainability Solutions recalls Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as elec
Recalled January 18, 2017 · FDA recall Z-0963-2017 · Stryker Sustainability Solutions
Hazard
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. · FDA Class II
Sold at
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.
Description
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
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.
Manufacturer(s)
Stryker Sustainability Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →