FDAClass IINovember 9, 2016

AC TenderLink 13/30 10 pcs recall

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…

Why was AC TenderLink 13/30 10 pcs recalled?

Tubing detachment

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
Unomedical As
Quantity
653,280 units
Distribution
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Recall date
November 9, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls