Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is removing all sizes of Monoject sterile syringes and enteral syringes from the market due to manufacturing and rebranding changes. Products were distributed in the 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 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: This product received FDA Class I classification, which requires a minimum severity score of 4. Although no illnesses or injuries are reported, manufacturing changes to sterile medical devices warrant this elevated classification.
Plain-English summary
Cardinal Health is expanding a previous product correction to a full removal of Monoject sterile syringes in multiple sizes, including Luer-Lock tip syringes (1, 3, 6, 12, 20, 35, 60 mL) and Enteral syringes with ENFit connection (1, 3, 6, 12, 35, 60 mL).
The product removal is due to changes in manufacturing and rebranding efforts. The FDA has classified this as a Class I recall.
The affected syringes were distributed nationwide in the United States and Canada, with affected lot numbers including 221201-221205 and 230201-230207.
Healthcare providers and consumers should check their inventory for affected lots and contact Cardinal Health with questions about the product removal and replacement options.
The recalled product
- Product
- Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Syringes
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 (15)
- UDI/DI 50192253034606 (Case)
- 20192253034605 (Box)
- 10192253034608 (Each)
- Lot Numbers: 221201
- 221202
- 221203
- 221204
- 221205
- 230201
- 230202
- 230203
- 230204
- 230205
- 230206
- 230207
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.
See all 13 products in this recall →Related recalls
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