medical MODERATE Updated 2017-01-18

Stryker Sustainability Solutions recalls Reprocessed Ablation Catheter Cable Catalog Number: CR3425C

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Recalled 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.

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Hazard / Issue

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

Issued by

FDA

Affected States: 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
Lot/Code Info: All lots with the following Expiration Date Scope: Between 3/1/2018 and 10/31/2018 (Also displayed as Mar-2018 to Oct-2018)

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall