MN-SMITHS-MEDICAL

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.

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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 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 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

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 .

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