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Lack of Assurance of Sterility
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)
Presence of foreign substance: Presence of Benzene.
Failed Dissolution Specifications
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.