FDA Alert on ENFit Low Dose Tip Syringes

FDA has issued a safety alert about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip (LDT) syringes. “The FDA 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 alert says. The moat area is unique to the device’s design, it says. 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. The agent has sent letters to the manufacturers requesting that they update their labeling and training materials to include information about the potential for overdose and steps users can take to optimize dose accuracy.