FDA-Device2015-12-23Class II
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.
Stryker Instruments Div. of Stryker Corporation
Hazard
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.
Sold states
Nationwide Distribution including PA and SC.
Affected count
120 units
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0417-2016Don't want to check this manually?
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