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Unomedical As recalls Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", H
Recalled November 9, 2016 · FDA recall Z-0355-2017 · Unomedical As
Hazard
Tubing detachment · FDA Class II
Units
1,295,515 units
Sold at
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Description
Tubing detachment
Product
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" 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 →