Reported Dec 23, 2015 · Terminated
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer…
Stryker Instruments Div. of Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- 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.
- Lot codes and dates
- Model Number(s)0910-192-000 Lot Numbers
- Affected 61406007 expiration date8/31/2015
- Amount recalled
- 120 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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