FDA MedWatch - Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe by Smiths Medical:

Recall - Due to Skewed Graduation Markings

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe by Smiths Medical: Class I Recall - Due to Skewed Graduation Markings AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Smiths Medical is recalling specific models and lots of Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes because they 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. For more information about the affected models and lot numbers, click on the red button "Read Recall" below. BACKGROUND: The Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes are used to administer insulin. RECOMMENDATIONS: 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. 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. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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