Health Canada — Medical Devices · Canada · 2019-04-04 · Type III
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Reported risk: Medtronic received notification from original equipment manufacturer: Advanced Medical Solutions (AMS) of a field action related to specific production lots of the SwiftSet product. AMS has received user complaints that the product has become solid and polymerizing before use. AMS's investigation confirms there is potentially a shortening of shelf life of the product. The adhesive may have prematurely started to or has completely polymerized within the ampoule rendering the adhesive too thick or completely solid, preventing the adhesive from being expressed from the device.
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