Reprocessed Diagnostic Electrophysiology — Class II medical device recall Z-0340-2014
Terminated recall by Stryker Sustainability Solutions, reported 2013-11-27, distributed in AZ, CA, OH. Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cabl
| Recall number | Z-0340-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2013-10-18 |
| Classified | 2013-11-18 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2013-12-06 |
| Distributed | AZ, CA, OH |
| Quantity | 46 units |
| Reason classes | sterility, packaging |
| Serial numbers | 1258475, 1313231, 1363123, 1401578, 1406041, 1434511, 1464987, 1471197, 1520424, 1529652, 1531413, 1533378, 1533385, 1535068, 1535071, 1535072, 1535540, 1535548, 1538579, 1538655, 1539560, 1539561, 1541119, 1558103, 1558826 and 21 more |
| Model numbers | 201101, 201104, 401442, 401661, 401860, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT, D6-DR-252-RT, D7-A20-131-RT, F6-QF-252RT |
Product
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Note: These devices do not support or sustain life. Diagnostic EP 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 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. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
Reason for recall
Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.
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-0340-2014. 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.