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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.
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.
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