Cardinal Health Enteral Syringes Recalled for Pump Incompatibility
Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) have compatibility issues with certain feeding pumps. The affected lots should not be used with enteral syringe 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 classified this as a Class I recall. Per the rubric, FDA Class I recalls require a minimum severity score of 4. The compatibility issue with critical enteral feeding devices poses significant potential for harm to patients dependent on nutrition support.
Plain-English summary
Cardinal Health Monoject Enteral Syringes with ENFit Connection System are being recalled due to recognition and compatibility issues with certain syringe enteral feeding pumps. The recall affects syringes in 6, 12, 35, and 60 mL sizes, with approximately 397,676 units distributed in the United States and Canada.
The syringes cannot properly connect or function with certain enteral feeding pumps, which could affect the delivery of nutrition to patients who depend on enteral feeding. Cardinal Health recommends that affected lots not be used with enteral syringe feeding pumps.
Affected lot numbers are 230501, 230701, and 230702. Patients and healthcare providers should immediately discontinue use of these units. For further information, contact Cardinal Health 200, LLC or consult FDA recall number Z-0850-2024.
The recalled product
- Product
- Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 397,676
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 26971564466251 (Case)
- 16971564466254 (Box)
- 06971564466257 (Each)
- Lot Numbers: 230501
- 230701 and 230702
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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