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 Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.. Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.. Classification: Class II. Quantity: 1,676 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.
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