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Recall Observatory FDA recall evidence

Device 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 percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.

Z-0417-2016

November 23, 2015

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 72775
Status
Terminated
Classification
Class II
Quantity
120 units
Official record key
device-enforcement:Z-0417-2016

Official wording

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

Distribution pattern: Nationwide Distribution including PA and SC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.