Monoject 12 mL Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health recalls 3 million Monoject 12 mL Luer-Lock syringes due to demonstrated compatibility issues with syringe infusion pumps that may affect medication delivery.
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: This is a Class I medical device recall as classified by the FDA. Per the severity rubric, FDA Class I recalls carry a minimum severity score of 4. The compatibility issues with infusion pumps present a potential risk of improper medication delivery.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 3,084,300 Monoject 12 mL Syringe Luer-Lock Tip Soft Pack units due to demonstrated recognition and compatibility issues with syringe infusion pumps.
The affected syringes have been distributed nationwide to all U.S. states. The recalled product codes are Lot Numbers 221101, 221102, 221103, and 221104, with UDI codes 10192253025811 (each), 20192253025818 (box), and 50192253025819 (case).
Healthcare facilities and individuals using these syringes should stop use and contact Cardinal Health 200, LLC for instructions on returns or replacements. Patients should consult their healthcare provider if they have questions about their medication delivery.
The recalled product
- Product
- Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 3,084,300
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 (8)
- Product Code: 1181200777T
- UDI/DI: 10192253025811 - each
- 20192253025818 - box
- 50192253025819 - case
- Lot Numbers: 221101
- 221102
- 221103
- 221104
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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