Cardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility
Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) in Lot 230503 and 230701 have compatibility issues with certain feeding pumps and should not be used.
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 per the severity rubric requires a minimum score of 4. No deaths or injuries have been reported.
Plain-English summary
Cardinal Health Monoject Enteral Syringes with ENFit connection (6, 12, 35, and 60 mL) in lot numbers 230503 and 230701 are being recalled due to recognition and compatibility issues with certain syringe enteral feeding pumps.
The affected syringes have recognition and compatibility problems when used with enteral feeding pump systems. Cardinal Health recommends these syringes should not be used with any enteral syringe feeding pumps due to these compatibility issues.
Approximately 20,186 units were distributed nationwide in the United States and in Canada. The affected product is identified by lot numbers 230503 and 230701.
Consumers and healthcare facilities should immediately discontinue use of the affected syringes with enteral feeding pumps. Contact Cardinal Health for guidance on returning or replacing the affected product.
The recalled product
- Product
- Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 20,186
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 (4)
- UDI/DI 26971564466220 (Case)
- 16971564466223 (Box)
- 06971564466226 (Each)
- Lot Numbers: 230503 and 230701
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.
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