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June 17, 2021Smiths Medical Issues Class I Recall of Insulin Syringes
June 16, 2021 – Smiths Medical has recalled multiple lots of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringes that may have skewed gradation markings on the syringe barrels. The markings may be skewed 20 degrees upward. The U.S. FDA has designated the recall a Class I Recall, meaning there is a reasonable probability that use of the affected product can cause serious adverse health consequences or death.
The incorrect markings on the Jelco syringes create potential for incorrect insulin administration. This can lead to hypoglycemia (not enough sugar in the blood) or hyperglycemia (too much sugar in the blood), both of which can cause serious harm, such as ketoacidosis and seizures, and may be fatal. As of the date of the recall, Smiths Medical had received no reports of death or serious injury related to the affected syringes.
Patients or caregivers who have any of the recalled syringes should not use them. They can verify if the product has been recalled by checking for the lot number on the syringe’s packaging. If a patient or caregiver has recalled syringes, they should contact the pharmacy, home healthcare provider, or medical facility that provided the syringe to arrange for return and replacement.
| Model Number | Product Name | Affected Lot Numbers |
|---|---|---|
| 428-1 | 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, 4062242 |
Questions regarding the recall can be submitted to Smiths Medical by phone at 1-800-258-5361, email at fieldactions@smiths-medical.com, or online at https://smiths-medical.custhelp.com. Adverse reactions and quality problems can be reported to the FDA through the agency’s MedWatch program.
A full copy of the recall announcement is available on the FDA’s website.
There is no impact to members through Benecard Central Fill.