Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.. Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.. Classification: Class II. Quantity: 1,141 units. Distribution: US Nationwide Distribution.
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Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
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Software anomaly in the patient positioning system may result in positional discrepancy.
Software anomaly in the patient positioning system may result in positional discrepancy.
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
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