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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- manufacturing-defect
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.
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