Cardinal Health Monoject Syringe and Enteral Syringe Removal Due to Manufacturing Changes
Cardinal Health is removing Monoject sterile syringes (Luer-Lock and Enteral with ENFit) from the market due to manufacturing and rebranding changes. Distribution affected US 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification per severity rubric requires Critical severity score. This is an expanded product removal due to manufacturing and rebranding changes.
Plain-English summary
Cardinal Health is removing all sizes of Cardinal Health Monoject sterile syringes from the market. The affected products include Monoject Luer-Lock syringes (1, 3, 6, 12, 20, 35, and 60 mL) and Monoject sterile Enteral Syringes with ENFit connection (1, 3, 6, 12, 35, and 60 mL).
The recall action is due to changes in manufacturing and rebranding efforts. The products were distributed in the United States and Canada.
Affected lot numbers include: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, and 230206.
The recalled product
- Product
- Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
- Manufacturer
- Cardinal Health 200, LLC
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 (14)
- UDI/DI 50192253034675 (Case)
- 20192253034674 (Box)
- 10192253034677 (Each)
- Lot Numbers: 221201
- 221202
- 221203
- 221204
- 221205
- 230201
- 230202
- 230203
- 230204
- 230205
- 230206
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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