Recall Z-0417-2016 ยท DYB Introducer, Catheter
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Dec 14, 2015 (initiated Nov 23, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 120 units |
| Distribution | Nationwide Distribution including PA and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K812973 | PERCUTANEOUS INTRODUCER COURNAND STYLE Dip, Inc., Nov 16, 1981 |