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FDA-Device2016-11-09Class II

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

Unomedical As
Hazard

Tubing detachment

Sold states
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Affected count
653,280 units
Manufactured in
Aholmvej 1 3 Osted, Roskilde, Denmark
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0357-2017

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