PlainRecalls
FDA Devices Moderate 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.

Reported: December 23, 2015 Initiated: November 23, 2015 #Z-0417-2016

Product 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 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.

Details

Units Affected
120 units
Distribution
Nationwide Distribution including PA and SC.
Location
Portage, MI

Frequently Asked Questions

What product was recalled?
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.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 120 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 23, 2015. Severity: Moderate. Recall number: Z-0417-2016.