Health Canada — Medical Devices · Canada · 2020-01-31 · Type II
As described by Health Canada — Medical Devices: Non-Reinforced Surgical Gowns, Fabric Reinforced Surgical Gowns & Royalsilk Non-Reinforced Surgical Gowns (2020-01-21)
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Reported risk: Cardinal Health is conducting this recall because the affected gowns were manufactured at locations that did not maintain proper environmental conditions as required by law, were not qualified by Cardinal Health and commingled with properly manufactured gowns. Cardinal Health cannot provide assurances that the identified item codes and lot numbers were properly sterilized. An improperly sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
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