Moderate riskFDA DeviceClass II

Cardinal Health Monoject Tuberculin Syringe recalled for wrong syringe type inside packaging

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.

From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls

What to do

  1. Check any Cardinal Health Monoject Tuberculin Syringes (Catalog 1180100777) you have on hand
  2. Verify the actual syringe type inside matches the package label before use
  3. Contact your supplier or Cardinal Health if you have affected product
  4. Do not use the syringes if you cannot confirm the contents match the label

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
198,900 units
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Classification
Class II
Recall number
Z-1768-2026

In the FDA's words

Description
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
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.

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