Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is removing Monoject sterile syringes in multiple sizes due to manufacturing and rebranding changes. The recall affects products distributed nationwide in the US and Canada.
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 an FDA Class I medical device recall, which requires a minimum severity score of 4 per the rubric. No illnesses or injuries are reported in the notice, and the specific manufacturing or safety concern is not detailed.
Plain-English summary
Cardinal Health is recalling all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Monoject sterile Enteral Syringes with ENFit connection (1, 3, 6, 12, 35, and 60 mL). The recall expands previous product correction actions.
The recall is due to a change in manufacturing and rebranding efforts. Affected products were distributed nationwide in the US and Canada. Lot numbers include 221101, 221102, 221103, and 221104.
The recalled product
- Product
- Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
- Manufacturer
- Cardinal Health 200, LLC
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 (7)
- UDI/DI 50192253025819 (Case)
- 20192253025818 (Box)
- 10192253025811 (Each)
- Lot Numbers: 221101
- 221102
- 221103
- 221104
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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 13 products in this recall →Related recalls
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