Class II U.S. Food and Drug Administration

Cardinal Health 200, LLC ChemoPlus gowns: Product Code recall: Affected gowns have the incorrect expiration date on the product packaging

Recall published 10 months ago

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.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0897-2026
Published
December 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Cardinal Health 200, LLC
Product type
Medical devices
Units affected
251,165 units
Distribution
Nationwide
Made in
United States
Lot / 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;
UPC codes
50885380172371, 20885380172370, 50885380172395, 20885380172394, 50885380172418, 20885380172417, 50885380172432, 20885380172431, 50885380172456, 20885380172455, 50885380173989, 50885380173996, 50885380173972, 50885380174009, 50885380172388, 50885380172401, 50885380172425, 50885380172449, 50885380172463

Products covered by this recall

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;

Check your product

The notice names 22 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 50885380172371
  • 20885380172370
  • 50885380172395
  • 20885380172394
  • 50885380172418
  • 20885380172417
  • 50885380172432
  • 20885380172431
  • 50885380172456
  • 20885380172455
  • 50885380173989
  • 50885380173996
  • 50885380173972
  • 50885380174009
  • 50885380172388
  • 50885380172401
  • 50885380172425
  • 50885380172449
  • 50885380172463

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • UDI-DI
  • LESS THAN

Model or item number

On the rating label, the box or the instruction sheet.

  • Lot # UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Cardinal Health 200, LLC — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Cardinal Health 200, LLC — 3651 Birchwood Dr, Waukegan, IL, 60085-8337

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Cardinal Health 200, LLC medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 50885380172371, 20885380172370, 50885380172395; lot code UDI-DI, LESS THAN; model number Lot # UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls