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.
FDA Recall Z-0417-2016 · Posted 2015-12-14
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeDYB
Date Initiated2015-11-23
Date Terminated2016-09-06
Product Quantity120 units
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.
Firm Action
Stryker sent an Urgent Medical Device Recall Notification letter dated November 24, 2015, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
For questions regarding this recall, please contact Stryker Instruments:
Monday-Friday 8am-5pm (EST)
269-389-2921
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including PA and SC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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