FDA Class I Recall: Smiths Medical Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe
The U.S. Food and Drug Administration (FDA) released Smiths Medical’s announcement stating it 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. The FDA has designated this issue as a Class 1 recall.
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.
Affected Models and Lot Numbers:
· 4428-1 Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 28Gx1/2” 1CC – 4046543 and 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 4062242
The lot number can be found on the packaging for the syringe. Do not use any syringes with the affected lot numbers. The patient or caretaker should contact the pharmacy, home healthcare provider or medical facility that provided the syringe to arrange for return of the syringe and replacement.
