Developers: | Smiths Medical |
Branches: | Pharmaceuticals, medicine, healthcare |
Content |
Diabetes mellitus
Main article: Diabetes mellitus
2021: Withdrawal of defective insulin syringes
In mid-June 2021, the American company Smiths Medical recalled its insulin syringes with a fixed Jelco Hypodermic Needle-Pro needle. Recall was assigned to Class 1 group as the violations identified could threaten patients' lives and health.
The inspection revealed that due to industrial failure, the scale applied to the body of the syringes may be skewed or fuzzy. As a result of irregularities in production, the marking was inclined upward by about 20 degrees. Such marriage dramatically increases the likelihood of administration of an incorrect dose of insulin, which can lead to hyperglycemia and ketoacidosis or hypoglycemia with convulsive syndrome. The most severe complication can be hypoglycemic coma - the extreme degree of hypoglycemia, developing with a rapid decrease in the concentration of glucose in the blood plasma and a sharp drop in glucose utilization by the brain. Such complications can cause serious injuries and even death, so the recall was given the most serious status.
According to the press release, so far the company has not received reports of fatalities or serious injuries related to this problem. Smiths Medical released recall notices and response forms to customers, and warned of the dangers of using defective syringes. All documents contain models and batch numbers of syringes that should be returned to the company for exchange and disposal.
Among the models affected are the Jelco Hypodermic Needle-Pro 28Gx1/2 '1CC fixed needle insulin syringe (model 4428-1, batches 4046543 and 4062235) and the Jelco Hypodermic Needle-Pro 29Gx1/2' 1CC fixed needle insulin syringe (model 4429-1, batches 4014096. 4031846. 4031845. 4040734. 4043536. 4046545. 4046546. 4062239. 4062240. 4062238 and 4062242[1]