The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom and Health Canada have issued medical device safety alerts on quality issues with various Cardinal Health surgical gowns and surgical packs respectively.
The manufacturer initiated the surgical gown voluntary recall because some of the affected gowns were manufactured at locations that did not maintain proper environmental conditions as required by law, were not qualified by the manufacturer and commingled with properly manufactured gowns.
As a result, the manufacturer cannot provide assurances that the affected gowns were properly sterilized. An improperly sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
If you are in possession of the affected products, please contact your supplier for necessary actions.
For details, please refer to the following links:
MHRA: https://mhra-gov.filecamp.com/s/gx7blAB1yVxN9spK/d
Health Canada: https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72307r-eng.php
Posted on 13 February 2020