Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle Manifolds

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected ProductThe FDA is aware that AVID Medical has issued a letter to affected customers recommending certain convenience kits be corrected by removing manifolds affected by the Medline Namic Angiographic Star Off Handle Manifold Recall prior to continued use. Affected devices: Description (Tray Name)NAV NumberModel/Item NumberUDI -DICardiac Cath Pack512628EAMC1000-0510809160377314Heart Cath, Self Regional5313767SELF131-0510809160408650SAMMC Angiography5308991SAMM066-1510809160388495Full List of Affected ProductWhat to DoIdentify and quarantine affected kits. Add warning labels to ensure affected Manifolds are not used.On April 29, AVID Medical sent all affected customers a letter recommending the following actions:Identify, segregate, and quarantine all impacted product.

Other components within the convenience kits can still be used once kit is properly labeled with the warning label below. Add warning labels to affected Avid kits to ensure all users are aware of the actions below and identified Medline recall notice. The label should be applied in a prominently visible location to end-users.

The location chosen should not cover any other critical product information found on existing product labeling. Contact your Sales Representative if pre-printed labels are needed. If use is unavoidable because failure to proceed would result in patient harm, the Manifolds must be used with extreme caution and vigilance.

In such cases:The user should perform a full flush of the Manifold and associated tubing with saline.Carefully examine the manifold and lines for any particulate.Do not use the Manifold and lines if any particulate is observed.Users should otherwise adhere to all usage guidelines and the Manifolds’ Instructions for Use.Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.Reason for CorrectionAVID Medical is correcting convenience kits containing Manifolds affected by the Medline Namic Angiographic Star Off Handle Manifold Recall.Medline identified the presence of particulate within the fluid path of the Manifolds. Particulate within the Manifold fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

This carries a risk of serious injury, such as tissue or organ ischemia, or death.As of June 30, AVID Medical has not reported any serious injuries or deaths associated with this issue.Device UseThe Namic Manifold is intended to be used for fluid management, contrast media and pressure monitoring.Contact InformationCustomers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact AVID Medical at complaints@owens-minor.com.Additional FDA Resources FDA Enforcement Report CDRH Medical Device Recall Database Related Recall: Manifold Recall: Medline Removes Namic Star Off Handle ManifoldsUnique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.