Health Canada — Medical Devices · Canada · 2016-05-25 · Type II
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Reported risk: B. Braun Medical Inc. has identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located. A tear results in a compromise to the sterile barrier of the product which may render the device non-sterile.
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