Cardinal Health Monoject sterile syringes recalled due to manufacturing changes
Cardinal Health is recalling all sizes of its Monoject sterile syringes (Luer-Lock and ENFit models) nationwide due to manufacturing and rebranding changes. The FDA classified this as a Class I recall.
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 medical device recalls are classified as Severe (score 4) in the absence of reported deaths or serious injuries. The Class I designation indicates a reasonable probability of serious adverse health consequences, but no specific hazard or patient harm has been documented in the source material.
Plain-English summary
Cardinal Health is removing from the market all sizes of its Monoject brand sterile syringes: Luer-Lock models in 1, 3, 6, 12, 20, 35, and 60 mL sizes, and ENFit connection models in 1, 3, 6, 12, 35, and 60 mL sizes. This action expands on previous product correction efforts.
The FDA has classified this as a Class I recall due to a change in manufacturing and rebranding efforts. Affected lot numbers include 221201, 230201, 230601, and 230602. The recalled products were distributed nationwide in the United States and in Canada.
Healthcare providers and consumers currently using these syringes should discontinue use immediately and contact Cardinal Health 200, LLC for replacement options or additional information. The syringe models affected include UDI codes: Case (50192253034699), Box (20192253034698), and Each (10192253034691).
The recalled product
- Product
- Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Syringe
- 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 (7)
- UDI/DI 50192253034699 (Case)
- 20192253034698 (Box)
- 10192253034691 (Each)
- Lot Numbers: 221201
- 230201
- 230601
- 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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