ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-st
FDA device recall Z-0897-2026 · posted 2025-12-11 · Open, Classified
Recall details
- Recalling firm
- Cardinal Health 200, LLC
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FYA
- Quantity affected
- 251,165 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2025-11-12
- Date posted
- 2025-12-11
- Location
- Waukegan, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve (K193327) | Cardinal Health200, LLC | 2020-03-20 |