Health Canada — Medical Devices · Canada · 2019-12-20 · Type II
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Reported risk: 3M Durapore Advanced Surgical Tape is being recalled due to unanticipated product performance in clinical settings with high humidity conditions and/or when the tape is exposed to normal and/or excessive amounts of oral secretions. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray, enabling the fibers to be accidentally ingested or aspirated. While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape in high moisture clinical applications has not fully met all of 3M's performance expectations.
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