FDAClass IIDecember 23, 2015

Cournand Modified 2-PC recall

Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the…

Why was Cournand Modified 2-PC 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number(s): 0910-192-000 Lot Numbers Affected 61406007 expiration date: 8/31/2015

Product
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the…
Recalling firm
Stryker Instruments Div. of Stryker Corporation
Quantity
120 units
Distribution
Nationwide Distribution including PA and SC.
Recall date
December 23, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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