The Recall Desk
HighFDA (Devices)·Z-0112-2024·Announced 2023-10-25

Monoject tuberculin syringes incompatible with certain IV connectors

Cardinal Health is recalling Monoject tuberculin syringes because the conical tip is incompatible with certain needleless IV connectors.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for an equipment incompatibility between syringes and certain IV connectors. The incompatibility represents a risk-of-harm to proper medication administration. No illnesses or injuries have been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack (Model 1180100777). The syringe contains a conical tip that is not compatible with certain needleless IV connectors.

This recall affects units with lot numbers 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, and 230601, distributed nationwide. Healthcare providers who have these syringes should stop using them with the identified incompatible connectors and contact Cardinal Health or the FDA for replacement or return instructions.

The recalled product

Product
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Manufacturer
Cardinal Health 200, LLC
Hazard
  • equipment-incompatibility

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 (11)

  • Model Number/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.