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Unomedical As recalls Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach
Recalled November 9, 2016 · FDA recall Z-0356-2017 · Unomedical As
Hazard
Tubing detachment · FDA Class II
Units
664,000 units
Sold at
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Description
Tubing detachment
Product
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" 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 →