Various Cardinal Health Sterile Packs (2016-11-02) — recall 55943
Health Canada — Medical Devices · Canada · 2016-11-18 · Type II
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Reported risk: Cardinal Health has been informed by Medtronic of a medical device correction in regards to Covidien Devon Light Gloves contained in presource kits. This correction has been initiated to update labeling of the instructions for use. Medtronic advises that on rare occasion, the Devon Light Glove may split upon application to the Devon Light Handle Adapter. A split in the glove can potentially lead to a breach in the sterile barrier between the glove and the handle adapter. The following statement will be added to the instructions for use to help staff ensure that the sterile field is maintained: "after application, inspect the light glove for barrier integrity".
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