Early Alert: Convenience Kit Issue from Medical Action Industries
The adaptors on Namic RA syringes, included in Medical Action Industries convenience kits, may unwind during clinical use. This failure can result in loose connections or complete disconnections.
Healthcare providers using Medical Action Industries convenience kits, specifically those containing Namic RA syringes, and hospital departments involved in vascular or interventional procedures.
The mechanical failure of the syringe adaptor presents significant clinical risks, including infection, blood loss, and air embolism. From a regulatory perspective, this alert suggests a potential for a Class I recall classification due to the life-threatening nature of the possible adverse events. Manufacturers of convenience kits should note the liability and safety implications of component failures within aggregated kits.
Quality and Supply Chain teams should identify and quarantine affected convenience kits containing Namic RA syringes. Clinical staff should be notified of the risk of adaptor unwinding, and QA should initiate a review of incident reports for air embolism or blood loss associated with these kits.
The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
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