Enteral Syringes Recalled for Incompatibility with Feeding Pumps
Cardinal Health Monoject Enteral Syringes with ENFit connections are recalled due to compatibility issues with certain syringe feeding pumps. The manufacturer recommends they 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 Class I classification per agency assessment. No deaths, serious injuries, or hospitalizations reported. Device incompatibility with feeding pumps creates a risk of improper enteral nutrition delivery.
Plain-English summary
Cardinal Health Monoject Enteral Syringes with ENFit connection system (12mL, purple, REF 412SE) are being recalled. The recall involves 60,760 units distributed in the United States and Canada.
The recalled syringes have recognition and compatibility issues with certain syringe enteral feeding pumps. These issues may prevent the syringes from working properly with or being recognized by those pumps.
Cardinal Health recommends that the affected syringes not be used with enteral syringe feeding pumps. Facilities and healthcare providers should verify the lot numbers and remove affected units from service. The lot numbers affected are 230501, 230502, and 230601.
The recalled product
- Product
- Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 60,760
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 26971564466237 (Case)
- 16971564466230 (Box)
- 06971564466233 (Each)
- Lot Numbers: 230501
- 230502 and 230601
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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