Smiths Medical has become aware of specific models and lots of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringes that may exhibit skewed odd-number line graduation markings on their syringe barrels. Markings skewed approximately 20 degrees upward have been identified.

As a result of this issue, there is potential for administration of an incorrect dose of insulin, which could result in hyperglycemia (which may lead to ketoacidosis) or hypoglycemia (which may lead to seizures). This may result in serious harm or death. Smiths Medical has received no reports of death or serious injury related to this issue.

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