AVID Medical issues correction for convenience kits containing recalled Medline Namic Star Off-Handle manifolds

AVID Medical has sent a letter to customers directing a correction of certain convenience kits that include manifolds affected by the Medline Namic Angiographic Star Off-Handle manifold recall.

The FDA classifies this recall as the most serious type because continued use of the uncorrected devices could cause serious injury or death. The correction does not require removal of the kits from use or sale, but the affected manifolds must be removed before further use.

Customers are instructed to identify, segregate, and quarantine the impacted kits, apply a warning label that is prominently visible without covering other critical information, and ensure the label is placed on the kits. Other components in the kits may continue to be used once the label is applied.

The affected products include specific cardiac cath and angiography kits identified by model numbers, such as the Cardiac Cath Pack, Heart Cath Self Regional, and SAMM Angiography kits.