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Cardinal Health 200, LLC: ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T Ch

Medical DevicesSource: FDA (device) · Date: 2025-12-17

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Cardinal Health 200, LLC
Product
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;
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the country of Canada.
Recall initiated
2025-11-12
Code info
Product Code Lot # UDI-DI (GTIN): CT5500T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN045 CS- 50885380172371 EA- 20885380172370; CT5502T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN044 CS 50885380172395 EA - 20885380172394; CT5503T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN036 CS 50885380172418 EA - 20885380172417; CT5504T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22EASN004 CS- 50885380172432 EA- 20885380172431; CT5505T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN043 CS- 50885380172456 EA- 20885380172455; DP5001GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN033 CS- 50885380173989 EA-20885380173988; DP5002GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22EASN020 CS- 50885380173996 EA-20885380173995; DP5003GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN020 CS- 50885380173972 EA-20885380173971; DP5004GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22BASN087 CS- 50885380174009 EA-20885380174008; CT5500TS 21KAS095 CS- 50885380172388 EA-20885380172387; CT5502TS 21KAS059 CS- 50885380172401 EA-10885380172403; CT5503TS 21KAS106, 21LAS004, 21LAS017 CS- 50885380172425 EA-10885380172427; CT5504TS 21KAS064, 21KAS072, 21KAS109 CS- 50885380172449 EA-10885380172441; CT5505TS 21KAS019, 21KAS031 CS- 50885380172463 EA-10885380172465;
Product quantity
251,165 units
Voluntary mandated
Voluntary: Firm initiated
City
Waukegan
State
IL
Country
United States
Event id
97976
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