Z-0963-2017Class II

Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed...

Name: Z-0963-2017 Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed...
Creator: Stryker Sustainability Solutions
Published: 2016-12-06
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2016-12-06 / Terminated / root cause: packaging

FDA source

Stryker Sustainability Solutions began a recall of Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on... on 2016-12-06. FDA classified it as Class II and gives the reason as "A breach in the sterile packaging may have occurred resulting in potentially non-sterile product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0963-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-06
Posted: 2017-01-07
Terminated: 2017-06-08
Recalling firm: Stryker Sustainability Solutions
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.
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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 [email protected]. 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.
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.
Product codes and lots: All lots with the following Expiration Date Scope: Between 3/1/2018 and 10/31/2018 (Also displayed as Mar-2018 to Oct-2018)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0963-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0963-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-07
Z-0964-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-07

Product code NLH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)