AVID Medical, Inc. — Class I: Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
AVID Medical, Inc. has initiated a Class I recall for specific models of the Halyard CARDIAC CATH TRAY SHANDS JAX kit due to a potential defect where the Medline syringe rotating adaptor may unwind during use. This failure can lead to a loose connection or complete disconnection between the syringe and the manifold.
This affects AVID Medical, Inc., clinical staff utilizing these specific cardiac catheterization trays, and quality departments responsible for monitoring component reliability in convenience kits.
A Class I designation indicates the FDA's assessment of a high risk for serious adverse health consequences or death. The mechanical failure of a connection in a cardiac catheterization setting could lead to procedural delays, blood loss, or air embolism. This recall highlights the regulatory risks associated with kit assembly and the dependency on the integrity of third-party components within a sterile tray.
Immediately identify and quarantine affected model numbers SHND401-04 and SHND401-05. Verify inventory for any cardiac catheterization trays containing the suspect Medline syringe rotating adaptor and initiate supplier quality reviews to assess the impact of this component failure on broader kit integrity.
Class I. Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.. Product: Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.. Firm: AVID Medical, Inc. (Toano VA United States). Status: Ongoing.
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