Unomedical A/S, a maker of single-use medical devices, is pulling about 130,000 insulin infusion products from the market because it might detach mid-infusion, according to the FDA.
Nearly 130,700 VariSoft Infusion Sets are being recalled, the FDA said Nov. 27. The connector could break from the Tandem insulin pumps without raising an alarm because of a manufacturing issue, and undetected detachments could lead to hyperglycemia.
One injury and no deaths have been reported.