Cournand Modified 2-PC 19G — Class II medical device recall Z-0417-2016
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2015-12-23, distributed nationwide. The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minima
| Recall number | Z-0417-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2015-11-23 |
| Classified | 2015-12-14 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2016-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 120 units |
| Model numbers | 0910-192-000 |
| Expiration dates | 2015-08-31 |
Product
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.
Reason for recall
The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a potential risk of a soft tissue infection to the patient if device is used after expiration date.
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-0417-2016. 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.