Reported Dec 22, 2021 · Ongoing

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011

Cardinal Health

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cardinal Health · 1270 Waukegan Rd Bldg C · Waukegan, IL · 60085-6722

Is this the product you have?

  • SmartSleeve Poly-Reinforced Breathable
  • Sleeve Surgical Gowns-Large SKU9011
Lot codes and dates
  • Lot Numbers
    • 20MFQ001
    • 20MFQ002
    • 20MFQ003
    • 21AFQ001
    • 21BFQ001
    • 21BFQ002
    • 21CFQ001
    • 21CFQ002
    • 21CFQ003
    • 21DFQ001
    • 21DFQ002
    • 21EFQ001
    • 21EFQ002
    • 21FFQ001
    • 21FFQ002
    • 21GFQ001
    • 21GFQ002
    • 21GFQ003
    • 21HFQ001
    • 21JFQ001
  • UDI50885380172500 (cs) 10885380172502 (ea)
Amount recalled
169,262 units

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential for open packaging seals compromising the sterility of the surgical gowns

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.