Cardinal Health recalls RoyalSilk Non-Reinforced Surgical Gowns with potential open packaging seals that could compromise sterility. Affected lots include 20MMQ007 through 21FMQ007. No remedy specified in recall notice.
Potential for open packaging seals compromising the sterility of the surgical gowns
Cardinal Health is recalling RoyalSilk Non-Reinforced Surgical Gowns (XXX-large, X-long) due to a risk that the packaging seals might not stay closed, which could lead to the gowns not being sterile. This is especially important for surgical staff who rely on sterile gowns during procedures.
The packaging seals on these surgical gowns might not stay closed properly, which could allow contamination. If the gowns are not sterile when used, it could lead to infections during medical procedures.
Surgical staff and healthcare workers who use these specific gowns for procedures are most at risk. Patients and others who might come into contact with the gowns could also be affected if the sterility is compromised.
Check for the SKU number 95998 on the gown label. Lot numbers 20MMQ007 through 21FMQ007 are affected. The UDI (Unique Device Identifier) codes 50192253006191 (cs) and 10192253006193 (ea) are also associated with this recall.
Look for the SKU number 95998 and lot numbers 20MMQ007 through 21FMQ007 on the gown label.
The recall states there is a potential risk that the packaging seals could compromise sterility, so they should not be used until the recall is addressed.
The recall does not specify a remedy, so you should check the product details to see if you have an affected item and contact Cardinal Health for further guidance.
Check for the SKU number 95998 and lot numbers 20MMQ007 through 21FMQ007 on the gown label.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0378-2022 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-0378-2022 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.