Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT — Class II medical device recall Z-0964-2017
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-0964-2017 |
|---|---|
| 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 | CB3410CT, CB3412CT, CB3434CT, D134401 |
Product
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
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-0964-2017. 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.