Monoject 1 mL Tuberculin Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health recalls approximately 3.1 million Monoject 1 mL Tuberculin Syringes due to demonstrated compatibility and recognition issues with syringe infusion pumps. Nationwide distribution affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which establishes a minimum severity score of 4 (Severe). No deaths or serious injuries are reported in the source material.
Plain-English summary
Cardinal Health 200, LLC is recalling Monoject 1 mL Tuberculin Syringes with Luer-Lock Tip distributed nationwide. Approximately 3.1 million units are affected, with lot numbers 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, and 230601.
The syringes are being recalled due to demonstrated compatibility and recognition issues when used with syringe infusion pumps. The FDA classified this as a Class I recall.
The affected syringes were distributed nationwide to all 50 states. Healthcare facilities and individuals who have received these products should discontinue use of the affected lot numbers and contact Cardinal Health 200, LLC or their healthcare provider for instructions regarding product return or replacement.
The recalled product
- Product
- Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 3,113,846
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 (13)
- Product Code: 1180100777
- UDI/DI: 10192253034530 - each
- 20192253034537 - box
- 50192253034538 - case
- Lot Numbers: 221201
- 221202
- 221203
- 230201
- 230202
- 230203
- 230204
- 230205
- 230601
Distribution
Part of a larger recall action
This product is one of 6 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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