Z-0417-2016 Class II Terminated
FDA device recall Z-0417-2016 was initiated by Stryker Instruments Div. Of Stryker Corporation on Nov 23, 2015 and is designated Class II. 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… The recall status is terminated (terminated Sep 6, 2016). Affected quantity: 120 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 23, 2015
- Initiation Date
- Nov 23, 2015
- Termination Date
- Sep 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 units
Product description
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.
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.
Distribution pattern
Nationwide Distribution including PA and SC.
Code information
Model Number(s): 0910-192-000 Lot Numbers Affected 61406007 expiration date: 8/31/2015
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0417-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026