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| - 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. This press release features multimedia. View the full release here: Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringes skewed graduation marking on the syringe barrel. (Photo: Business Wire) Affected Models and Lot Numbers: -0- *T Model NumberNameLot 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 *T 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. 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 at1-(800)-258-5361. Consumers may also contact Smiths Medical online at 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 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, visit www.smiths-medical.com. 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 source version on businesswire.com: Contact Doug Shook 619-886-0504 douglas.shook@smiths-medical.com © 2021 Business Wire, Inc. Disclaimer: This material is not an AFP editorial material, and AFP shall not bear responsibility for the accuracy of its content. In case you have any questions about the content, kindly refer to the contact person/entity mentioned in the text of the release.
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