FDA-Device2026-04-08Class IIMISBRANDING
Cardinal Health Monoject Tuberculin Syringe recalled for wrong syringe type inside packaging
What this means
Cardinal Health Monoject Tuberculin Syringes labeled as 1 mL Luer Lock (Catalog 1180100777) actually contain U-100 Insulin syringes inside the packages. This mislabeling could lead to incorrect dosing if the syringes are used without checking the actual contents. The affected lot numbers are 531164X and 531162X.
- Check any Cardinal Health Monoject Tuberculin Syringes (Catalog 1180100777) you have on hand
- Verify the actual syringe type inside matches the package label before use
- Contact your supplier or Cardinal Health if you have affected product
- Do not use the syringes if you cannot confirm the contents match the label
The agency's original wording
Hazard
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
198,900 units
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1768-2026More Cardinal Health recalls
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