Health Canada — Medical Devices · Canada · 2021-01-22 · Type II
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Reported risk: Olympus Medical Systems Corp. Identified an abnormality during the packaging process of certain lot numbers of single-use products. Due to the anomaly, is it possible that the sterility of these products may be compromised due to a defective seal. This breach may be difficult to detect with the naked eye. Olympus has not received any reported complaints regarding compromised sterile package heat seals or injury associated with this matter. To prevent potential risk to patient health, Olympus will notify facilities who have received the affected lot numbers and request that the devices be quarantined and return to Olympus.
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