The devicemaker said June 17 that some of the needles have markings skewed about 20 degrees upward. The defect could cause incorrect doses of insulin to be given to patients, which could result in hyperglycemia or hypoglycemia.
The defect could cause serious harm or death, the FDA said. The agency has designated it a class 1 recall, the most serious.
Smiths Medical said it hasn’t received any reports of serious injury or death related to the recall.
Read the full news release here.
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