Stryker Sustainability Solutions: Medical Device Recall in 2017 - (Recall #: Z-0963-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 6, 2016

Date Posted: January 18, 2017

Recall Number: Z-0963-2017

Event ID: 75941

Reason for Recall:

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

Status: Terminated

Product Quantity:

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.

Voluntary or Mandated:

Voluntary: Firm initiated