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FDA-Device2025-12-17Class IIMISBRANDING

Cardinal Health ChemoPlus gowns recalled for incorrect expiration date labeling

Cardinal Health
EXPIRATION DATE ERRORNationwide distribution

Check expiration dates on ChemoPlus gowns

Cardinal Health ChemoPlus protective gowns and sleeves have been mislabeled with a five-year shelf life when the actual shelf life is three years. The affected gowns may be used past their true expiration date if the incorrect label is relied upon. No injuries have been reported.

  • Check if you have ChemoPlus gowns with lot numbers and product codes matching the recall list
  • Do not use any affected gowns beyond three years from their manufacture date
  • Contact your supplier or Cardinal Health for replacement or further instructions
  • Review the complete lot number and product code list on the FDA website to confirm if your inventory is affected
Hazard

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
251,165 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile; CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0897-2026

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