Insulin syringes recalled due to “skewed graduated marks” that may lead to over or under dosage of insulin

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A recall has been issued for Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes from Smiths Medical. The recall is the most urgent type of recall, a Class I recall, according to the Food and Drug Administration.

The syringe in question is a one-time use syringe for drawing and injecting insulin (U-100) into a patient.

The affected syringes may cause life threatening over-dosage or underdosage of insulin due to skewed graduated marks on syringe barrels.

The barrel of the syringe is the part of a syringe that shows measurements to ensure correct dosages for the medications they are used to administer.

According to the FDA, the affected products may have graduated markings on the barrel that are printed incorrectly. Specifically, the syringe barrell’s odd numbered graduation markings may be skewed approximately 20 degrees upward.

A Class I recall is the highest urgency category of recall issued by the FDA. According to the FDA, a Class I recall means the circumstances of the recall create a “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The affected syringes were distributes from October 31, 2020 to January 10, 2021. Lot and model numbers are listed below. Lot number can be located on the packaging for the syringe.

Model numberNameLot number
4428-1Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 28Gx1/2” 1CC4046543, 4062235
4429-1Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2” 1CC4014096, 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238, 406224

Consumers with questions regarding this recall may contact Smiths Medical via telephone at 1-(800)-258-5361. Consumers may also contact Smiths Medical online at https://smiths-medical.custhelp.com.

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