Monoject tuberculin syringe packages actually contain U-100 insulin syringes
Cardinal Health is recalling two lots of Monoject Tuberculin Syringes because the packaging identifies them as 1 mL Luer Lock tuberculin syringes but the contents are U-100 insulin syringes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the syringes inside are graduated differently from the ones the packaging names, and no injuries are stated in the source.
Plain-English summary
Cardinal Health is recalling the Monoject Tuberculin Syringe, 1 mL Luer Lock, catalogue number 1180100777. About 198,900 units were distributed nationwide in the United States and to Canada. The FDA has classified this recall as Class II.
The outer packaging and blister pack labeling identify the product as a 1 mL Luer Lock Tuberculin Syringe (product code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
Affected product carries UDI/DI 10884521013414 for each, 20884521013411 for the box and 30884521013418 for the case, across lots 531164X and 531162X.
Facilities can identify affected syringes by the catalogue number, UDI and lot numbers above, and may contact Cardinal Health for further information.
The recalled product
- Product
- Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Syringe
- Affected units
- 198,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI 10884521013414 (each)
- 20884521013411 (box)
- 30884521013418 (case)
- Lot Numbers: 531164X
- 531162X
Distribution
Distributed nationwide across the United States.
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