Manufacturing error on syringe barrels prompts Smiths Medical into global product recall

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.

The company, which is a supplier of specialised medical devices and equipment for global markets, 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.

This action has been designated as a Class 1 recall by the US FDA.

Last year, Smiths Medical entered into a a strategic public–private partnership with Biomedical Advanced Research and Development Authority (BARDA), part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, and the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND).

The partnership expanded capacity at the Smiths Medical facility in Keene, New Hampshire, for production of integrated hypodermic needle and syringe products to support the government’s COVID-19 vaccination efforts.