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Unomedical As recalls AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; A
Recalled November 9, 2016 · FDA recall Z-0357-2017 · Unomedical As
Hazard
Tubing detachment · FDA Class II
Units
653,280 units
Sold at
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Description
Tubing detachment
Product
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Manufacturer(s)
Unomedical As
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →