Smiths Medical’s Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes Recalled Due to “Skewed Graduated Marks”
On June 28, 2021, Smiths Medical initiated a recall of two models of its Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes due to a dangerous manufacturing defect. The affected Smiths Medical insulin syringes were recalled due to “skewed graduated marks” that could cause either an over-dosage or an under-dosage of insulin. The U.S. Food and Drug Administration classified the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe recall was designated as a Class I recall, which is the most serious and urgent type of recall. The recalled syringes are single-use syringes for injecting and drawing insulin (U-100).
The Reason for the Recall
According to the U.S. FDA, the recalled syringes have graduated markings on the syringes barrel were incorrectly printed. The syringe’s barrel displays measurements to make sure the proper dosages are administered to the patient. The recall notice states that the affected “syringe barrel’s odd-numbered graduation markings may be skewed approximately 20 degrees upward.” The affected insulin syringes could lead to a life-threatening under-dosage or over-dosage of insulin due to defective graduated marks on the syringe barrels.
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 Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes were sold from October 31, 2020 to January 10, 2021. The recalled insulin syringes’ lots and model numbers are posted below. The syringes’ lot numbers are located on the syringe packaging.
Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 28Gx1/2″ 1CC”
Model number: 4428-1
Lot Numbers: 4046543, 4062235
Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2” 1CC
Model number: 4429-1
Lot Numbers: 4014096, 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238, 406224
Medical professionals and consumers with concerns or questions about the recall should contact Smiths Medical online at www.smiths-medical.custhelp.com.
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