Cardinal Health recalls RoyalSilk Non-Reinforced Surgical Gowns X-large (SKU 9548) due to potential open packaging seals compromising sterility. Affected lot numbers and UDI provided for identification.
Potential for open packaging seals compromising the sterility of the surgical gowns
Cardinal Health is recalling RoyalSilk Non-Reinforced Surgical Gowns X-large (SKU 9548) because the packaging seals might not stay closed, risking contamination during surgery. This could lead to infections if the gowns are used without proper sterility.
The packaging seals on these surgical gowns may open unexpectedly, allowing contaminants to enter the gown. This could compromise the sterility required for surgical procedures, increasing infection risk.
Surgical staff and hospitals using the RoyalSilk Non-Reinforced Surgical Gowns X-large (SKU 9548) with the listed lot numbers. Those handling the gowns during procedures are most at risk of contamination.
Check for the SKU 9548 on the gown label. Look for lot numbers: 20MMQ004 through 21HMQ006. The unique device identifier (UDI) 50192253006177 (cs) or 10192253006179 (ea) is also associated with these items.
Look for SKU 9548, lot numbers listed in the recall notice, and the UDI codes 50192253006177 (cs) or 10192253006179 (ea).
The packaging seals on these surgical gowns may open unexpectedly, potentially compromising sterility during use.
Check for SKU 9548, lot numbers 20MMQ004 through 21HMQ006, or UDI codes 50192253006177 (cs) or 10192253006179 (ea).
The recall notice does not specify a remedy, so contact Cardinal Health directly for guidance.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0376-2022 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-0376-2022 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.
