RECALL ALERT: Class I Recall Issued for Insulin Syringes with Skewed Graduation Markings

The FDA has just announced that Smiths Medical has issued a voluntary Class I recall of some of its insulin syringes due to inaccurate markings on the barrels of the syringes. The company says the skewed graduation markings could lead to improper doses of insulin, which could result in serious injury or death.

Smiths Medical is recalling 13 lots of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe. These include:

• Model number 4428-1 Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe 28Gx1/2″ 1CC. Lot numbers 4046543 and 4062235.
• Model number 4429-1 Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe 29Gx1/2″ 1CC. Lot numbers 4014096, 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238 and 4062242.

According to the FDA’s announcement of the recall on their website, the affected syringes have skewed odd number lines on their barrels, which could lead to users getting too much or too little insulin and suffering from hypoglycemia or hyperglycemia.

The FDA says “markings skewed approximately 20 degrees upward have been identified.”

As of now, Smiths Medical, a leading supplier of specialized medical devices and equipment for global markets, has not received any reports of death or injury related to the recall. The company is sending out recall notices and response forms to purchasers to instruct them on what to do with the affected syringes.

Customers who have an affected product in their possession should not use it. Instead, they should quarantine and return the product. Contact the pharmacy, home healthcare provider, or medical facility that provided the product to arrange a return.

If you’ve used one of these products and experienced an adverse reaction or quality problem, please report it to the FDA’s MedWatch Program at www.fda.gov/medwatch or call 1-800-FDA-1033.

Customers with questions can reach out to Smiths Medical via phone at 1-(800)-258-5361 or online at https://smiths-medical.custhelp.com/. Specific questions can also be directed to fieldactions@smiths-medical.com.