FDA issues recall, alerts for certain convenience kits; companies voluntarily recall certain IV fluids

The Food and Drug Administration has identified a Class I recall of certain convenience kits by AVID Medical that contain recalled Medline Namic Angiographic Star Off Handle Manifolds. The FDA said that Medline discovered particulate matter within the fluid path of the manifolds. AVID Medical has not reported any serious injuries or deaths associated with the issue as of June 30. The company issued correction actions for the kits. An early alert was also issued for AVID Medical convenience kits containing recalled BD ChloraPrep applicators due to fungal contamination that may occur under certain environmental conditions.

The FDA also issued early alerts for other medical products: certain esophageal pH monitoring capsules by Medtronic, due to the potential of the capsule not attaching to the patient's esophagus or not detaching from the delivery device as intended; and all Imager II Angiographic Catheters by Boston Scientific, due to a manufacturing issue affecting the catheter tip.

Certain intravenous solutions have also been voluntarily recalled: two lots of 0.9% Sodium Chloride Injection by Baxter due to the potential presence of particulate matter identified as fiberglass in the solution; and three lots of 0.9% Sodium Chloride Injection, 100 mL, in a 150 mL Partial Additive Bag by B. Braun Medical, due to the presence of particulate matter identified as zinc oxide.