Medical devices supplier Smiths Medical, affiliated to Smiths Group plc, is recalling certain Jelco Hypodermic Needle-Pro Fixed Needle insulin syringes with skewed graduation markings, the U.S. Food and Drug Administration said.
The recall was initiated after the company became aware of specific models and lots of Jelco insulin syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company has identified markings that skewed approximately 20 degrees upward.
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.
However, Smiths Medical has not received any reports of death or serious injury related to this issue to date.
The recall includes Jelco insulin syringe 28Gx1/2″ 1CC with model number 4428-1 and lot numbers 4046543 and 4062235.
The affected products also include Jelco insulin syringe 29Gx1/2″ 1CC with model number 4429-1, and lot numbers 4014096, 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238 and 4062242.
The patients or caretakers are urged to contact the pharmacy, home healthcare provider or medical facility that provided the syringe to arrange for return of the syringe and replacement.
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