ChemoPlus recallZ-0897-2026 · Cardinal Health 200, LLC · initiated Nov 12, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On November 12, 2025, firm began notifying customers via Urgent Medical Device Product Recall letters. Customers were instructed to segregate and quarantine all affected product upon review of inventory. All affected product should be returned to the firm. Customers who have further distributed affected product should notify any customers impacted by this recall.
Recall details
- Recall number
- Z-0897-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 12, 2025
- Posted by the FDA
- Dec 11, 2025
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 251,165 units
- Product code
- FYA
- FDA submissions
- K193327
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
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;
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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;
Devices named in this recall
14 devices in the FDA device registry whose identifier appears in the recall's code information.
- ChemoPlus CT5502TSCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus CT5503TSCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus CT5504TSCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus CT5505TSCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus CT5500TCardinal Health 200, LLC · ACCESSORY, SURGICAL APPAREL1 recall0 reports
- ChemoPlus CT5500TSCardinal Health 200, LLC · ACCESSORY, SURGICAL APPAREL1 recall0 reports
- ChemoPlus CT5502TCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus CT5503TCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus CT5504TCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus CT5505TCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus DP5003GTCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus DP5001GTCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus DP5002GTCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
- ChemoPlus DP5004GTCardinal Health 200, LLC · GOWN, SURGICAL1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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