Health Canada — Medical Devices · Canada · 2020-04-17 · Type II
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Reported risk: Avanos Medical (formerly Halyard Health) has received 3 complaint reports stating that the Corflo* PEG tube may be blocked at the center of the adapter (occluded). Avanos reviewed its inventory and demonstrated the defect rates to be 1.4% for full occlusion and 2.2% for partial occlusion, based on lots produced after the implementation of the suspected root cause. A PEG tube that is occluded may not be functional and the PEG procedure may be delayed or aborted. A new PEG tube placement may be required to continue with the procedure. There is no need for concern in patients who have had PEGs placed that function normally, which are de facto unoccluded.
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