Smiths Medical has received no reports of death or serious injury related to this issue
Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes skewed graduation marking on the syringe barrel. (Credit: Business Wire.)
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.
Smiths Medical is issuing Recall Notices and Response Forms to consignees of Affected Models and Lot Numbers to instruct them that they must quarantine and return the product.
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.
Source: Company Press Release