Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Ne
FDA device recall Z-0417-2016 · posted 2015-12-14 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Action taken
- Stryker sent an Urgent Medical Device Recall Notification letter dated November 24, 2015, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-2921
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 120 units
- Distribution
- Nationwide Distribution including PA and SC.
- Date initiated
- 2015-11-23
- Date posted
- 2015-12-14
- Date terminated
- 2016-09-06
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERCUTANEOUS INTRODUCER COURNAND STYLE (K812973) | Dip, Inc. | 1981-11-16 |