Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward by approximately 20 degrees.
With the issue, there is potential for the administration of an incorrect dose of insulin, which could result in hyperglycemia (which may lead to ketoacidosis) or hypoglycemia (which may lead to seizures). These may result in serious harm or death. As such, the FDA designated the recall as Class 1, the most serious kind.
According to a news release, the company has received no reports of death or serious injury related to the issue and issued recall notices and response forms to consignees of affected models and lot numbers so that users will quarantine and return the affected product.
Affected models and lot numbers:
|
Model |
Name |
Lot Number |
|
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 |
