Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT recalled over sterility concerns

Recall date

December 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Sustainability Solutions recalls Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electro…

Recall number

Z-0963-2017

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

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.

Why it was recalled

A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.