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Z-0357-2017 Class II Terminated

Recalled by Unomedical As — Roskilde

FDA device recall Z-0357-2017 was initiated by Unomedical As on Nov 7, 2014 and is designated Class II. Reason for recall: Tubing detachment The recall status is terminated (terminated Nov 16, 2016). Affected quantity: 653,280 units.

Recall details

Product Type: Devices
Report Date: Nov 9, 2016
Initiation Date: Nov 7, 2014
Termination Date: Nov 16, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 653,280 units

Product description

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

Reason for recall

Tubing detachment

Distribution pattern

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

Code information

5032433, 5033654, 5037164, 5040419, 5044362, 5046682, 5051308, 5053298, 5058508, 5061927, 5062202, 5065546, 5069297, 5072252, 5075118, 5044359, 5053289, 5061929, 5032436, 5033657, 5037159, 5040420, 5044355, 5046683, 5051309, 5053299, 5058501, 5061928, 5062205, 5065539, 5069295, 5072249, 5032442, 5033662, 5037162, 5040424, 5044361, 5051304, 5053292, 5058505, 5061931, 5061933, 5062208, 5032438, 5037160, 5044360, 5051310, 5053300, 5062211, 5069296, 5072253, 5032439, 5032440, 5033659, 5033660, 5037161, 5040422, 5044365, 5046684, 5051303, 5053297, 5058503, 5061939, 5062212, 5065550, 5065551, 5069298, 5072250, 5075121, 5032441, 5033661, 5037167, 5040423, 5044366, 5046681, 5051311, 5053293, 5058504, 5061930, 5065552, 5069301, 5072254, 5033658, 5044363, 5062206, 5062207, 5065540, 5065541, 5065542, 5069302, 5072251

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0357-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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