AVID Medical Issues Class I Recall for Kits with Contaminated Medline Manifolds

The U.S. Food and Drug Administration (FDA) has announced a Class I recall, the most serious type, for certain convenience kits distributed by AVID Medical. This correction involves kits containing Medline Namic Star Off Handle Manifolds, which are affected by a prior recall due to particulate contamination.

Medline identified particulate within the fluid path of these manifolds. If introduced into blood circulation, this particulate could become lodged in blood vessels, posing a risk of serious injury such as tissue or organ ischemia, or even death. AVID Medical has advised affected customers to remove these manifolds from their kits before continued use, though no serious injuries or deaths have been reported as of June 30.

The FDA emphasized the gravity of the situation, stating, "This recall involves correcting certain devices by removing components affected by another recall. 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." Customers with questions should contact AVID Medical at complaints@owens-minor.com.