The Recall Desk
SevereFDA (Devices)·Z-0150-2024·Announced 2023-11-01

Monoject 60 mL Syringes Recalled for Infusion Pump Compatibility Issues

Cardinal Health is recalling 457,200 Monoject 60 mL Luer-Lock tip syringes due to demonstrated compatibility issues with certain infusion pump systems. The affected syringes may fail to function correctly with these pumps.

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 applies to this recall. While no reported illnesses or injuries are stated in the source, the demonstrated incompatibility with infusion pumps presents significant risk of medication delivery failure or device malfunction.

Plain-English summary

Cardinal Health 200, LLC is recalling Monoject 60 mL Syringe Luer-Lock Tip Soft Pack units due to demonstrated recognition and compatibility issues with syringe infusion pumps.

The syringes have shown compatibility problems that may prevent them from functioning correctly when used with certain infusion pump systems. This incompatibility could result in improper medication delivery or pump malfunction.

The recall affects 457,200 units distributed nationwide across all U.S. states. The affected product is identified by Lot Numbers 221101 and 230601. Healthcare facilities and providers using these syringes with infusion pumps should immediately verify compatibility and consider discontinuing use if compatibility cannot be confirmed.

Patients and healthcare providers who have concerns about affected syringes or experience any issues with medication delivery when using these products should contact Cardinal Health 200, LLC or consult with their healthcare provider.

The recalled product

Product
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Manufacturer
Cardinal Health 200, LLC
Hazard
  • device-incompatibility
  • malfunction

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 (6)

  • Product Code: 1186000777T
  • UDI/DI: 10192253025835 - each
  • 20192253025832 - box
  • 50192253025833 - case
  • Lot Numbers: 221101
  • 230601

Distribution

Distributed nationwide across the United States.