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

Class I Recall - Due to Skewed Graduated Marks on Syringe Barrel That May Cause Insulin Overdose or Underdose

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes by Smiths Medical: Class I Recall - Due to Skewed Graduated Marks on Syringe Barrel That May Cause Insulin Overdose or Underdose  AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Smiths Medical is recalling the affected products because these insulin syringes may have graduated markings that are printed incorrectly on the syringe barrel. Specifically, the "odd numbered" graduation markings on the syringe barrel may be skewed approximately 20 degrees upward. If the skewed markings are used to measure an insulin dose, patients may receive too much or too little insulin. This overdose or underdose of insulin can lead to serious patient harm, including death. There have been nine complaints, no injuries, and no deaths reported for this issue. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe is a one-time use syringe used to draw and inject a common formulation of insulin (U-100) into a patient. RECOMMENDATIONS: On May 17, 2021, Smiths Medical sent an urgent medical device recall notice to distributors and clinical users of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe. The letter requested that customers: Locate affected product in your possession by referring to the Affected Devices List. Determine the number of affected devices in your possession and complete the Response Form and return the form. Return all affected products for processing. A prepaid label will be provided after Smiths Medical receives the completed response form. 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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