Monoject 6 mL Syringes Recalled Due to Infusion Pump Incompatibility
Cardinal Health is recalling Monoject 6 mL Luer-Lock syringes (approximately 3.9 million units) nationwide due to demonstrated recognition and compatibility issues with syringe infusion pumps.
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: The FDA has classified this recall as Class I, which requires a minimum severity score of 4. Although no illnesses or injuries have been reported, the demonstrated recognition and compatibility issues with infusion pumps present a potential patient safety risk.
Plain-English summary
Cardinal Health 200, LLC is recalling Monoject 6 mL Syringe Luer-Lock Tip Soft Pack units distributed nationwide. Approximately 3.9 million units have been distributed across all 50 states.
The FDA has classified this as a Class I recall due to demonstrated recognition and compatibility issues between these syringes and syringe infusion pumps. These issues may affect the ability of infusion pumps to properly recognize or function with the syringe.
Affected product includes units with lot numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206, and 230207. Healthcare facilities and other users of these syringes should verify lot numbers and contact Cardinal Health or their healthcare provider regarding affected units.
The recalled product
- Product
- Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Syringes
- Affected units
- 3,936,682
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 (16)
- Product Code: 1180600777
- UDI/DI: 10192253034608 - each
- 20192253034605 - box
- 50192253034606 - case
- Lot Numbers: 221201
- 221202
- 221203
- 221204
- 221205
- 230201
- 230202
- 230203
- 230204
- 230205
- 230206
- 230207
Distribution
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
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