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# FDA Article Examines ENFit Syringe Dosing Errors
- URL: https://www.fdaweb.com/fda-article-examines-enfit-syringe-dosing-errors/
- Published: 2021-11-19T12:00:00.000Z
- Updated: 2026-09-14T17:22:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150616

CDRH [says](https://www.fda.gov/medical-devices/safety-communications/potential-medication-overdose-enfit-low-dose-tip-syringe-fda-safety-communication?ref=fdaweb.com) a recent article published in the *Journal of Clinical Pharmacy and Therapeutics* entitled [Assessing Dosing Errors in Legacy and Low Dose Tip ENFit Syringes](https://onlinelibrary.wiley.com/doi/10.1111/jcpt.13559?ref=fdaweb.com) sheds some light on an agency safety alert about the risk of medication overdose from the moat area of ENFit LDT syringes.

Last month, FDA issued the alert saying it is “aware of the potential for overdose if the user does not clear the moat area around the tip of the ENFit LDT syringe before administering a medication.” The moat area is unique to the device’s design, FDA said. The syringes are generally used to deliver fluids either orally or through the gastrointestinal tract (enterally) into the body. ENFit LDT syringes are manufactured and distributed by several manufacturers in syringe sizes between 0.5 mL and 6 mL.

In the new study, a research team at FDA assessed the risk of medication overdose by using computer-aided modeling to analyze the maximum possible dosing errors in 0.5 mL and 1.0 mL ENFit LDT syringes and traditional syringes under various clinical use conditions, including varied filling and administration methods.

“Study results showed dosing errors are possible for both traditional syringes and the ENFit LDT syringes, depending on the filling and administration methods used,” CDRH says. The agency believes that dose accuracy using ENFit LDT syringes can be optimized when users follow provided [recommendations](https://www.fda.gov/medical-devices/safety-communications/potential-medication-overdose-enfit-low-dose-tip-syringe-fda-safety-communication?ref=fdaweb.com#rec).