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A limited number of IV bags have been found to leak during filling.
There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Potential presence of foreign objects.
Contains chicken contaiminated with Listeria monocytogenes
Undeclared allergens; sesame
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Affected device lots have labels that state the incorrect expiration dates.
The product is being recalled due to an undeclared allergen - tree nuts (walnuts).
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
CGMP violations.