Monoject 20 mL Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health is recalling 4.9 million Monoject 20 mL Luer-Lock syringes due to compatibility and recognition issues with infusion pumps. Affected lot numbers from 2022 and 2023 were distributed nationwide.
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 classification indicates reasonable probability of serious adverse health consequences, establishing a minimum severity level of 4. Although no illnesses or injuries are reported, the demonstrated compatibility and recognition issues with critical infusion pump systems present significant risk to proper medication delivery.
Plain-English summary
Cardinal Health 200, LLC is recalling 4,913,520 Monoject 20 mL Syringe Luer-Lock Tip Soft Pack units due to demonstrated compatibility and recognition issues with syringe infusion pumps.
The syringes may not be properly recognized or may not operate compatibly with infusion pump systems. No illnesses or injuries have been reported. The recalled product has Product Code 1182000777 and includes lot numbers 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, and 230206.
The affected syringes were distributed nationwide across all 50 U.S. states and territories. Healthcare providers and users should immediately discontinue use of syringes from the recalled lot numbers and contact Cardinal Health for replacement or return instructions.
The recalled product
- Product
- Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Syringes
- Affected units
- 4,913,520
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)
- Product Code: 1182000777
- UDI/DI: 10192253034677 - each
- 20192253034674 - box
- 50192253034675 - case
- Lot Numbers: 221201
- 221202
- 221203
- 221204
- 221205
- 230201
- 230202
- 230203
- 230204
- 230205
- 230206
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.
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