Tuesday, October 12, 2021

Potential for Medication Overdose with ENFit Low Dose Tip Syringe

How to optimize dose accuracy when using ENFit LDT syringes.

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FDA - Center for Devices and Radiological Health

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Potential for Medication Overdose with ENFit Low Dose Tip Syringes - FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication informing patients and health care providers about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip (LDT) syringes.

The FDA is providing recommendations for patients and health care providers to promote the safe use of ENFit LDT syringes, including the steps users can take to optimize dose accuracy. When using the recommended steps included in the safety communication, the dose accuracy of the ENFit LDT syringes is equivalent to the dose accuracy of traditional syringes.

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This safety communication provides:

  • Recommendations for health care providers, patients, and their caregivers.
  • The FDA's actions to address the issue.
  • Background and analysis of the issue.
  • Instructions for reporting problems with ENFit LDT syringes to the FDA.

 Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).


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