Recall database
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Lack of Assurance of Sterility
Defective Container; packets were found to be either empty or partially full.
Potential contamination with foreign objects (metal pieces).
Potential contamination with foreign objects (metal pieces).
Potential contamination with foreign objects (metal pieces).
Potential contamination with foreign objects (metal pieces).
Potential contamination with foreign objects (metal pieces).
Presence of Particulate matter: Particulate matter identified as glass.
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
Imported Enoki Mushrooms tested positive for Listeria Monocytogenes.
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.