Convenience Kit Recall: AVID Medical Removes Convenience Kits Containing Namic RA Syringes
AVID Medical has initiated a recall for convenience kits containing Namic RA syringes due to a defect where the syringe adaptor may unwind during use. This mechanical failure can result in a loose connection or total disconnection.
This affects AVID Medical, healthcare facilities utilizing their convenience kits, and clinical personnel performing procedures involving Namic RA syringes. Affected departments include clinical operations, supply chain, and quality assurance.
The potential for syringe adaptor disconnection presents significant clinical risks, including infection, blood loss, and air embolism. From a regulatory perspective, this indicates a critical failure in component integrity within a finished kit. Organizations may need to evaluate the impact on surgical workflows and ensure that substitute kits or components meet sterilized procedural requirements.
Immediately identify and quarantine all listed convenience kits containing Namic RA syringes. Quality teams should conduct a reconciliation of distributed inventory and prepare for formal retrieval or field correction procedures as dictated by the manufacturer's recall instructions. Clinical staff should be alerted to the specific risk of syringe adaptor disconnection.
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.
Open in openFDA / FDA.gov