—#142281

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.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K812973
Affected lot / code info: Model Number(s): 0910-192-000 Lot Numbers Affected 61406007 expiration date: 8/31/2015

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.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Nationwide Distribution including PA and SC.

Timeline

Recall initiated: 2015-11-23
Posted by FDA: 2015-12-14
Terminated: 2016-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142281. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.