FDA Enforcement
Class II
Terminated
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.
Recall: Z-0417-2016
·
Reported December 23, 2015
Enforcement
- Recall Number
- Z-0417-2016
- Event ID
- 72775
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Instruments Div. of Stryker Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 23, 2015
- Initiation Date
- November 23, 2015
- Classification Date
- December 14, 2015
- Termination Date
- September 6, 2016
- Address
- 4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States
Description
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
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.
Code Info
Model Number(s): 0910-192-000 Lot Numbers Affected 61406007 expiration date: 8/31/2015
Distribution
Nationwide Distribution including PA and SC.
Quantity
120 units