Health Canada — Medical Devices · Canada · 2015-05-26 · Type II
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Reported risk: Manufacturer has identified compromises in sterile packaging that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may not be easily seen. Manufacturer has not received any complaints of injury associated with compromised sterile packaging. However, it is possible that use of non-sterile product may introduce microbes and increase the potential for postoperative infection.
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