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Safety Report: Hypodermic Needle Insulin Syringes - recalled due to skewed markings on syringes, USA

3 years ago •source fda.gov

Recall notice

United States

Company name: Smiths Medical
Brand name: Jelco
Product recalled: Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Reason of the recall: Skewed odd number line graduation markings on syringe barrels.
FDA Recall date: June 17, 2021
Recall details: Company Announcement 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. Affected Models and Lot Numbers:

- Model Number: 4428-1
- Name: Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe 28Gx1/2” 1CC
- Lot Number: 4046543 and 4062235

- Model Number: 4429-1
- Name: Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe 29Gx1/2” 1CC
- Lot Number: 4014096, 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238 and 4062242

Please reference the attachment for an illustration of the skewed graduation marking on the syringe barrel.

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.

Home Healthcare Environments: 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.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-worldwide-notification-regarding-recall-jelcor-hypodermic-needle-pror-fixed

Source: FDA

#medicaldevices #recall #us

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