# Ne oldu?

AVID Medical has issued a formal correction for convenience kits that contain Medline Namic Star Off Handle Manifolds. The U.S. Food and Drug Administration (FDA) MedWatch alert emphasizes that these devices, if used without the required correction, may cause serious injury or death. This action affects specific product lots used in cardiac catheterization and angiography procedures.

# Ayrıntılar

The correction applies to specific Cardiac Cath Packs and Heart Cath kits identified by NAV numbers 512628 and 5313767, as well as SAMMC Angiography kits with NAV number 5308991. Affected model/item numbers include EAMC1000-05, SELF131-05, and SAMM066-15. The FDA report identifies the Medline Namic Star Off Handle Manifold as the component posing the risk.

AVID Medical recommends that healthcare facilities immediately identify all impacted kits, segregate them from usable stock, and quarantine the units. Crucially, the affected kits must be labeled with the provided warning label. Other components within the convenience kits may still be used once the kit is properly labeled. If proceeding with use is unavoidable due to the potential for patient harm, the manifolds must be used with extreme caution. This includes performing a full saline flush of the manifold and associated tubing and carefully examining the manifold and lines for any particulate matter.

# Neden önemli?

Patient safety is the primary concern. The Namic Star Off Handle Manifold, if defective or used incorrectly, presents a risk of serious adverse events. By issuing this correction, AVID Medical and the FDA aim to prevent potential harm by ensuring that medical staff are aware of the specific kits affected and the necessary steps to mitigate risk. Proper identification and labeling are critical to ensuring that these high-risk devices are not inadvertently used without the necessary safety precautions.

# Sırada ne var?

Healthcare facilities and distributors should review their inventory for the affected NAV numbers and model numbers. Customers who received product from a distributor are advised to contact the distributor or relevant channels for further guidance. AVID Medical continues to work with facilities to ensure the correction process is completed efficiently to maintain patient safety standards.