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Unomedical As recalls SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Pa
Recalled November 9, 2016 · FDA recall Z-0360-2017 · Unomedical As
Hazard
Tubing detachment · FDA Class II
Units
4,748,000 units
Sold at
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Description
Tubing detachment
Product
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm 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 →