130K insulin infusion sets recalled

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. 

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By: Paige Twenter

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.

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