Convenience Kit Recall: American Contract Systems Removes Convenience Kits Containing Namic RA Syringes
American Contract Systems is removing convenience kits containing Namic RA Syringes because the syringe adaptor may unwind during use. This mechanical failure can result in loose connections or complete disconnections during clinical procedures.
This recall affects American Contract Systems, healthcare providers utilizing their convenience kits, and procurement departments managing surgical or interventional inventory.
The potential for adaptor unwinding introduces significant clinical risks, including infection, blood loss, and air embolism. This alert suggests a critical component failure within a bundled kit, highlighting the regulatory responsibility of kit assemblers to manage the safety signals of constituent components. Operational impacts likely include immediate inventory sequestration and a need for rigorous reconciliation of affected lot numbers.
Immediately identify and quarantine all convenience kits containing Namic RA Syringes within inventory. Update internal risk assessments to include potential mechanical failures of adaptors and ensure that clinical users are briefed on the specific failure mode (unwinding) to prevent adverse events.
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