Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT — Class II medical device recall Z-0963-2017
Terminated recall by Stryker Sustainability Solutions, reported 2017-01-18, distributed in AK, AL, AZ, CA, CO, CT, DC, DE…. A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
| Recall number | Z-0963-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2016-12-06 |
| Classified | 2017-01-07 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-06-08 |
| Distributed | AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IN, KS, MD, MI, MN, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI |
| Reason classes | sterility |
| Model numbers | CR3425CT, CR3434CT |
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.
Reason for recall
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0963-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.