The Recall Desk
SevereFDA (Devices)·Z-0145-2024·Announced 2023-11-01

Monoject 1 mL Tuberculin Syringes Recalled for Infusion Pump Compatibility Issues

Cardinal Health recalls approximately 3.1 million Monoject 1 mL Tuberculin Syringes due to demonstrated compatibility and recognition issues with syringe infusion pumps. Nationwide distribution affected.

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: The FDA classified this recall as Class I, which establishes a minimum severity score of 4 (Severe). No deaths or serious injuries are reported in the source material.

Plain-English summary

Cardinal Health 200, LLC is recalling Monoject 1 mL Tuberculin Syringes with Luer-Lock Tip distributed nationwide. Approximately 3.1 million units are affected, with lot numbers 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, and 230601.

The syringes are being recalled due to demonstrated compatibility and recognition issues when used with syringe infusion pumps. The FDA classified this as a Class I recall.

The affected syringes were distributed nationwide to all 50 states. Healthcare facilities and individuals who have received these products should discontinue use of the affected lot numbers and contact Cardinal Health 200, LLC or their healthcare provider for instructions regarding product return or replacement.

The recalled product

Product
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Manufacturer
Cardinal Health 200, LLC
Hazard
  • pump-incompatibility
  • syringe-recognition-failure

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 (13)

  • Product Code: 1180100777
  • UDI/DI: 10192253034530 - each
  • 20192253034537 - box
  • 50192253034538 - case
  • Lot Numbers: 221201
  • 221202
  • 221203
  • 230201
  • 230202
  • 230203
  • 230204
  • 230205
  • 230601

Distribution

Distributed nationwide across the United States.