Health Canada — Medical Devices · Canada · 2021-07-29 · Type II
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Reported risk: Boddingtons Plastics LTD. (Boddingtons), became aware of an irregularity in the packaging process of the subject products which could lead to a packaging seal defect. This product is supplied sterile and a bread of the package's sterile barrier might lead to patient infection. The risk of infection is considered extremely improbably due as the devices are intended for use in the lower gastrointestinal tract. However, Boddingtons is conducting a recall to inform customers and users of this possibility and offer a credit for the return of any products with this packaging anomaly.
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