In a letter to customers, Cardinal Health issued an “Urgent Medical Device Recall” for some of its surgical gowns.
“The purpose of this letter is to advise you that Cardinal Health is voluntarily recalling specific production lots of single-sterile and bulk non-sterile Cardinal Health™ Non-Reinforced Surgical Gowns, Cardinal Health™ Fabric-Reinforced Surgical Gowns and RoyalSilk® Non-Reinforced Surgical Gowns. The affected gowns were distributed between September 1, 2018 and January 10, 2020. Note that gowns manufactured prior to 2018 are not affected by this recall,” the letter reads.
“The affected surgical gowns also are used as components in Cardinal Health™ Presource® Kits, which are not part of this recall, but will be subject to a separate field action at a later date. At this time, continue to segregate and discontinue use of surgical packs that include affected gowns from your current inventory,” the letter continues. “Packs with lot numbers not listed on the spreadsheet provided by your Cardinal Health sales representative are not affected by this recall.”
“We are working closely with the U.S. Food and Drug Administration (“FDA”) to address this issue,” it continues.
The letter goes on to explain that “Cardinal Health is conducting this recall because some of the affected gowns were manufactured at locations that did not maintain proper environmental conditions as required by law, were not registered with the FDA, were not qualified by Cardinal Health and commingled with properly manufactured gowns. As a result, 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.”
The letter is signed by Senior Vice President of Regulatory Affairs D. Linden Barber.
The letter may be viewed online at https://tinyurl.com/GownRecall.