Z-0417-2016Class II

Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire...

Name: Z-0417-2016 Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2015-11-23
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2015-11-23 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2015-11-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0417-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-23
Posted: 2015-12-14
Terminated: 2016-09-06
Recalling firm: Stryker Corp.
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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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
Quantity in commerce: 120 units
Distribution: Nationwide Distribution including PA and SC.
Product codes and lots: Model Number(s): 0910-192-000 Lot Numbers Affected 61406007 expiration date: 8/31/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0417-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0417-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-14

Product code DYB

K812973Class IIPercutaneous Introducer Cournand StyleDip, Inc. / cleared 1981-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)