Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is classified as an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls receive a Critical (5) designation, indicating a reasonable probability of serious adverse health consequences related to the manufacturing and product control concerns identified.
Plain-English summary
Cardinal Health is recalling all sizes of their Monoject sterile Luer-Lock syringes and Monoject sterile Enteral syringes with ENFit connections. The products are being removed due to manufacturing and rebranding efforts. This action represents an expansion of a previous product correction to a complete removal.
The recalled Luer-Lock syringes are available in 1, 3, 6, 12, 20, 35, and 60 mL sizes. The Enteral syringes with ENFit connection are available in 1, 3, 6, 12, 35, and 60 mL sizes. All sizes are being recalled. The products have been distributed throughout the United States and Canada.
Affected individuals and healthcare facilities should immediately stop using these syringes. Contact Cardinal Health for instructions on return, replacement, or disposal of the recalled products. Healthcare providers should review their inventory and remove any affected syringes from use.
The recalled product
- Product
- Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- manufacturing-defect
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 50192253025833 (Case)
- 20192253025832 (Box)
- 10192253025835 (Each)
- Lot Numbers: 221101
- 230601
Distribution
Distributed nationwide across the United States.
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