Smiths Medical Recalls Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes

If your email program has trouble displaying this email, view as a webpage. Smiths Medical Recalls Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes for Skewed Graduated Marks on Syringe Barrel That May Cause Insulin Overdose or Underdose FDA's Center for Veterinary Medicine is sharing news of this recall to alert veterinarians who may be using this product. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product: Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes Model Number Name Lot Number 4428-1 Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 28Gx1/2" 1CC 4046543, 4062235 4429-1 Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2" 1CC 4014096, 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238 and 406224 Distribution Dates: October 31, 2020 to January 10, 2021 Devices Recalled in the U.S.: 1,431,000 Date Initiated by Firm: May 14, 2021 Device Use The Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe is a one-time use syringe used to draw and inject a common formulation of insulin (U-100) into a patient. Reason for Recall Smiths Medical is recalling the affected products because these insulin syringes may have graduated markings that are printed incorrectly on the syringe barrel. Specifically, the "odd numbered" graduation markings on the syringe barrel may be skewed approximately 20 degrees upward. If the skewed markings are used to measure an insulin dose, patients may receive too much or too little insulin. This overdose or underdose of insulin can lead to serious patient harm, including death. There have been nine complaints, no injuries, and no deaths reported for this issue.   You are subscribed to updates from FDA's Center for Veterinary Medicine.

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