FDA-Device2026-04-08Class II

Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

Cardinal Health 200, LLC
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.
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-1768-2026

Original summary

Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 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. UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X Distribution: Worldwide distribution - US Nationwide and the country of Canada. Affected quantity: 198,900 units

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