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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

ChemoPlus Protective Gowns and Sleeves Recalled for Incorrect Expiration Date

Agency Publication Date: December 11, 2025
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Summary

Cardinal Health 200, LLC is recalling 251,165 units of ChemoPlus protective gowns and sleeves because the product packaging lists an incorrect expiration date. While the products are labeled with a five-year shelf life, they actually only have a validated shelf life of three years. This recall includes various styles of gowns and sleeves, including sterile and non-sterile options in multiple sizes and back configurations. Using these products past their actual three-year expiration date could compromise the protective barrier or sterility, posing a risk to patients and healthcare workers.

Risk

The gowns and sleeves may lose their protective integrity or sterility after their true three-year expiration date. This could result in healthcare workers being exposed to hazardous chemicals like chemotherapy drugs or patients developing infections during medical procedures if a non-sterile gown is used.

What You Should Do

  1. This recall affects ChemoPlus Full Coverage Gowns and Sleeves, including sterile and non-sterile versions in sizes ranging from Regular/Medium to Extra Extra Large.
  2. Identify affected products by checking the packaging for product codes CT5500T, CT5502T, CT5503T, CT5504T, CT5505T, DP5001GT, DP5002GT, DP5003GT, DP5004GT, CT5500TS, CT5502TS, CT5503TS, CT5504TS, or CT5505TS.
  3. See the Affected Products section below for the full list of affected codes and lot numbers.
  4. Stop using the recalled gowns and sleeves. Contact Cardinal Health 200, LLC or your medical supply distributor to arrange for a return, replacement, or correction of the affected items.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile
Variants: Universal Size, Medium Blue, Non-sterile
Model / REF:
CT5500T
Lot Numbers:
All lot numbers less than or equal to 22GASN045
GTIN:
50885380172371
20885380172370
Product: ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile
Variants: Regular/Medium, Medium Blue, Non-sterile, Closed Back
Model / REF:
CT5502T
Lot Numbers:
All lot numbers less than or equal to 22GASN044
GTIN:
50885380172395
20885380172394
Product: ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile
Variants: Large, Medium Blue, Non-sterile, Closed Back
Model / REF:
CT5503T
Lot Numbers:
All lot numbers less than or equal to 22GASN036
GTIN:
50885380172418
20885380172417
Product: ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile
Variants: Extra Large, Medium Blue, Non-sterile, Closed Back
Model / REF:
CT5504T
Lot Numbers:
All lot numbers less than or equal to 22EASN004
GTIN:
50885380172432
20885380172431
Product: ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile
Variants: Extra Extra Large, Medium Blue, Non-sterile, Closed Back
Model / REF:
CT5505T
Lot Numbers:
All lot numbers less than or equal to 22GASN043
GTIN:
50885380172456
20885380172455
Product: ChemoPlus Full Coverage Gown, Open Back, Large, Medium Blue, Non-sterile
Variants: Large, Medium Blue, Non-sterile, Open Back
Model / REF:
DP5001GT
Lot Numbers:
All lot numbers less than or equal to 22GASN033
GTIN:
50885380173989
20885380173988
Product: ChemoPlus Full Coverage Gown, Open Back, Extra Large, Medium Blue, Non-sterile
Variants: Extra Large, Medium Blue, Non-sterile, Open Back
Model / REF:
DP5002GT
Lot Numbers:
All lot numbers less than or equal to 22EASN020
GTIN:
50885380173996
20885380173995
Product: ChemoPlus Full Coverage Gown, Open Back, Medium, Medium Blue, Non-sterile
Variants: Medium, Medium Blue, Non-sterile, Open Back
Model / REF:
DP5003GT
Lot Numbers:
All lot numbers less than or equal to 22GASN020
GTIN:
50885380173972
20885380173971
Product: ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, Medium Blue, Non-sterile
Variants: Extra Extra Large, Medium Blue, Non-sterile, Open Back
Model / REF:
DP5004GT
Lot Numbers:
All lot numbers less than or equal to 22BASN087
GTIN:
50885380174009
20885380174008
Product: ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile
Variants: Universal Size, Medium Blue, Sterile
Model / REF:
CT5500TS
Lot Numbers:
21KAS095
GTIN:
50885380172388
20885380172387
Product: ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Sterile
Variants: Regular/Medium, Medium Blue, Sterile, Closed Back
Model / REF:
CT5502TS
Lot Numbers:
21KAS059
GTIN:
50885380172401
10885380172403
Product: ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile
Variants: Large, Medium Blue, Sterile, Closed Back
Model / REF:
CT5503TS
Lot Numbers:
21KAS106
21LAS004
21LAS017
GTIN:
50885380172425
10885380172427
Product: ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile
Variants: Extra Large, Medium Blue, Sterile, Closed Back
Model / REF:
CT5504TS
Lot Numbers:
21KAS064
21KAS072
21KAS109
GTIN:
50885380172449
10885380172441
Product: ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile
Variants: Extra Extra Large, Medium Blue, Sterile, Closed Back
Model / REF:
CT5505TS
Lot Numbers:
21KAS019
21KAS031
GTIN:
50885380172463
10885380172465

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97976
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: Medical supply distributors; Healthcare facilities; Direct sales from Cardinal Health
Manufactured In: United States
Units Affected: 251,165 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.