Cardinal Health Monoject Syringes and Enteral Syringes Removed
Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.
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 recalls warrant a minimum severity score of 4 (Severe) per regulatory guidance. The source contains no reports of injuries, illnesses, or deaths from these products.
Plain-English summary
Cardinal Health is removing all Monoject sterile Syringe Luer-Lock (all sizes) and Monoject sterile Enteral Syringes with ENFit connection (all sizes) from distribution. This includes Luer-Lock syringes in 1, 3, 6, 12, 20, 35, and 60 mL, and ENFit syringes in 1, 3, 6, 12, 35, and 60 mL. The removal is due to manufacturing changes and rebranding efforts.
The affected lot numbers are 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, and 230601. These products have been distributed nationwide in the United States and Canada.
Healthcare providers and consumers who have these products should contact Cardinal Health for guidance. This is an FDA Class I recall.
The recalled product
- Product
- Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Syringes
- Hazard
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 (12)
- UDI/DI 50192253034538 (Case)
- 20192253034537 (Box)
- 10192253034530 (Each)
- Lot Numbers: 221201
- 221202
- 221203
- 230201
- 230202
- 230203
- 230204
- 230205
- 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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