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
- Company
- Stryker Sustainability Solutions
- Recall Initiated
- December 6, 2016
- Posted
- January 7, 2017
- Terminated
- June 8, 2017
- Recall Number
- Z-0964-2017
- Firm Location
- Tempe, AZ
Reason for Recall
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Distribution
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.
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)
Root Cause
Under Investigation by firm
Action Taken
Customer notification letters were sent 12/06/16. Customers were asked to use the criteria of Item Number and Expiration Date to determine if any affected product remains in inventory. Use of the products from the affected item number and expiration date should be discontinued. Customers are instructed to follow the web link below to complete the Recall Effectiveness Check Form and indicate if any devices with the affected item number and expiration date listed above remain in inventory. ONLINE form must be completed even if no affected product is found. Use Stryker Sustainability Solutions Ship To Account Number as complete the form. If do not know your Ship To Account Number, contact local sales representative or call Stryker Sustainability Solutions Customer Care at 1-888-763-8803 to obtain this number. If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to facility for all affected devices in scope of this recall that are returned. Address any questions regarding the recall to Novasyte by calling (760) 279-3126 or emailing sss151@novasyte.com. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1-888-763-8803 http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.