Cardinal Health recalls Presource Procedure Packs containing AAMI Level 3 surgical gowns produced between September 2018 and January 2020. The gowns may not be sterile, increasing surgical site infection risk. Check catalog numbers and lot codes listed for affected items.
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
Cardinal Health is recalling Presource Procedure Packs with AAMI Level 3 surgical gowns produced between September 2018 and January 2020. The gowns were manufactured without proper environmental controls, which means they may not be sterile. This could increase the risk of surgical site infections during procedures.
The surgical gowns were manufactured at facilities that did not maintain proper environmental conditions. This lack of control means the gowns may not be sterile, which could compromise the surgical field and lead to infections in patients.
Healthcare professionals who use these surgical gowns during procedures are most at risk. Patients undergoing surgery with these gowns could face a higher risk of infection.
Check for catalog numbers and lot codes listed in the recall notice: PB08GAGHS 521235, PB08GAGHS 529320, PB08GAGHS 554815, and other specific combinations listed in the full recall details. These items were produced between September 2018 and January 2020.
Review the catalog number and lot code on the Presource Procedure Packs to confirm if they are affected. Affected items have specific catalog numbers and lot codes listed in the recall notice.
The surgical gowns were manufactured at facilities that did not maintain proper environmental conditions, which means they may not be sterile. This could increase the risk of surgical site infections during procedures.
Check the catalog number and lot code on the Presource Procedure Packs to see if they are affected. If they are, contact Cardinal Health for instructions on how to handle them.
Yes, patients undergoing surgery with these gowns could face a higher risk of infection due to the potential lack of sterility in the gowns.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1301-2020 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-1301-2020 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
