Cardinal Health Monoject Syringes Removal Due to Manufacturing Changes
Cardinal Health is removing Monoject brand syringes due to manufacturing changes and rebranding efforts. The removal includes Luer-Lock and ENFit connection models distributed nationwide in the US and Canada.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device removal. Per regulatory requirements, FDA Class I recalls are never scored below 4. Although the notice does not articulate a specific safety hazard beyond manufacturing changes, the Class I classification indicates the agency has determined a reasonable probability of serious adverse health consequences.
Plain-English summary
Cardinal Health is removing Monoject brand sterile syringes from the market due to manufacturing changes and rebranding efforts. The removal includes both Luer-Lock models (1, 3, 6, 12, 20, 35, and 60 mL) and ENFit connection models (1, 3, 6, 12, 35, and 60 mL).
The affected syringes were distributed throughout the United States and in Canada. Affected lot numbers are 230501, 230701, and 230601. Products can be identified by UDI codes 26971564466213 (case level), 16971564466216 (box level), and 06971564466219 (individual unit level).
The FDA has classified this as a Class I removal, the agency's most serious category for medical devices.
The recalled product
- Product
- Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
- 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 (6)
- UDI/DI 26971564466213 (Case)
- 16971564466216 (Box)
- 06971564466219 (Each)
- Lot Numbers: 230501
- 230701
- 230601
Distribution
Distributed nationwide across the United States.
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