Stryker Guidewire Introducer Needles Recalled for Expiration Date Issues
Stryker is recalling 120 units of Guidewire Introducer Needles shipped after expiration or with minimal time remaining due to infection risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with a potential risk of soft tissue infection, but the source text does not report any actual illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 120 units of Cournand Modified 2-PC 19G, 5.4cm Guidewire Introducer Needles (Model Number 0910-192-000). The affected lot number is 61406007, with an expiration date of 8/31/2015. These devices are designed for the percutaneous puncture of blood vessels to provide entry for guidewires, vessel dilators, sheaths, and catheters.
The recall was initiated because the devices were shipped after the documented expiration date or with minimal time until expiration. The source text notes a potential risk of soft tissue infection to the patient if the device is used after the expiration date.
The affected units were distributed nationwide, including Pennsylvania and South Carolina. Healthcare facilities and consumers should stop using these specific units and contact Stryker for further instructions or replacement.
The recalled product
- 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 120
Distribution
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