Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ChemoPlus Gown and Sleeve

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ChemoPlus Gown and Sleevesee related information
Date Initiated by FirmNovember 12, 2025
Date PostedDecember 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0897-2026
Recall Event ID 97976
510(K)NumberK193327 
Product Classification Gown, surgical - Product Code FYA
ProductChemoPlus 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 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;
FEI Number 3001236905
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information ContactCustomer Service
888-444-5440
Manufacturer Reason
for Recall		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 Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce251,165 units
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FYA
-
-