Menu Home NEWS Worldwide Notification Regarding the Recall of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe with Skewed Graduation Markings CONTACT US for more information June 17, 2021 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 Name Lot Number 4428-1 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 and 4062242 Please reference the below image 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. Smiths Medical has received no reports of death or serious injury related to this issue. 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. Additional Information: This action has been designated as a Class 1 recall by the U.S. Food and Drug Administration (FDA). 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. Smith Medical Contact Information Consumers with questions regarding this recall may contact Smiths Medical via telephone at 1-(800)-258-5361. Consumers may also contact Smiths Medical online at https://smiths-medical.custhelp.com. Specific questions on the recall should be directed to fieldactions@smiths-medical.com. FDA MedWatch Reporting Adverse reactions or quality problems experienced with the use of these products may also be reported to the FDA’s MedWatch Program by: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1033 Fax: 1-800-FDA-0178 Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852 Contact Doug Shook 619-886-0504 Douglas.shook@smiths-medical.com About Smiths Medical A leading supplier of specialized medical devices and equipment for global markets, focusing on the medication delivery, vital care and safety devices market segments. For more information click here >> About Smiths Group A global technology company that has been operating for nearly 170 years, delivering products and services for the medical technology, security and defense, general industrial, energy and space and commercial aerospace markets worldwide. Smiths Group plc employs c. 23,000 colleagues in over 50 countries and is listed on the London Stock Exchange. For more information visit www.smiths.com. View 9 View 30 View 60 View 90 JELCO® Needle-Pro® EDGE™ Sharps Safety Products Hypodermic Injections JELCO® Blunt Fill Needle Sharps Safety Products Hypodermic Injections JELCO® Hypodermic Needle-Pro® Device Sharps Safety Products Hypodermic Injections JELCO® Hypodermic Needle-Pro® EDGE™ Fixed Needle TB Syringe Sharps Safety Products Hypodermic Injections JELCO® Hypodermic Needle-Pro® EDGE™ Sharps Safety Products Hypodermic Injections JELCO® Hypodermic Needle-Pro® EDGE™ Detachable TB Syringes Sharps Safety Products Hypodermic Injections ONLINE SUPPORT NOT AVAILABLE IN ALL REGIONS BRANDS PRODUCTS CUSTOMER SUPPORT COMPANY INFORMATION Smiths Medical is part of the global technology business Smiths Group plc. Product(s) described may not be licensed or available for sale in all countries. BCI, CADD, Deltec, Graseby, Jelco, Level 1, Medex, Medfusion, Pneupac, Portex, Surgivet, Smiths Medical and all corresponding design marks are trademarks of Smiths Medical. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners. Please see the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions. Legal NoticeSmiths Medical Privacy PolicyCookie PolicyCA Legal InformationExplanation of MRI CompatibilityLinks Copyright 2021 - All rights reserved.