Stryker Sustainability Solutions: Medical Device Recall in 2017 - (Recall #: Z-0964-2017)

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 Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables either interface an EP catheter with the appropriate external stimulation or recording equipment or, serve as an extension cable between an EP catheter and equipment out of immediate reach

Product Classification:

Class II

Date Initiated: December 6, 2016

Date Posted: January 18, 2017

Recall Number: Z-0964-2017

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