Unomedical As recalls Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-

Recalled November 9, 2016 · FDA recall Z-0358-2017 · Unomedical As

Hazard

Tubing detachment · FDA Class II

Units

22,114 units

Sold at

Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.

Description

Tubing detachment

Product

Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 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 →