Cardinal Health Enteral Feeding Syringes Recalled for Pump Compatibility Issues
Cardinal Health Monoject enteral syringes in sizes 6mL to 60mL have compatibility issues with certain feeding pumps and may not properly connect. Cardinal Health recommends not using these syringes with enteral feeding pumps.
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: FDA Class I recall of medical device with compatibility issues that could impair proper feeding in patients dependent on enteral nutrition. No injuries or illnesses currently reported.
Plain-English summary
Cardinal Health is recalling Monoject enteral syringes with ENFit connection systems in sizes 6mL, 12mL, 35mL, and 60mL due to recognition and compatibility issues with certain enteral feeding pumps. These syringes may fail to properly recognize or connect with certain syringe feeding pump models, preventing proper nutrient delivery to patients who depend on enteral feeding.
Approximately 223,056 units have been distributed throughout the United States and Canada. The affected lot numbers are 230501, 230601, and 230602.
Cardinal Health is recommending these syringes not be used with enteral feeding pumps. Patients and healthcare providers should discontinue use of affected units and contact Cardinal Health or their healthcare provider for guidance on replacement syringes and alternative feeding administration options.
The recalled product
- Product
- Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 223,056
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 26971564466244 (Case)
- 16971564466247 (Box)
- 06971564466240 (Each)
- Lot Numbers: 230501
- 230601 and 230602
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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