Reported Nov 9, 2016 · Terminated

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;…

Unomedical As

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Unomedical As · Aholmvej 1 3 Osted · Roskilde · N/A

Is this the product you have?

8 of 8 products

Products covered by this recall
#Product as published
1AC TenderLink 13/30 10 pcs
2AC TenderLink I 13/60 10 pcs
3AC TenderLink I 13/80 10 pcs
4AC TenderLink I 17/110 10 pcs
5AC TenderLink I 17/30 10 pcs
6AC TenderLink I 17/60 10 pcs
7AC TenderLink I 17/80 10 pcs
8AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Lot codes and dates
  • 91 of 91 codes

    • 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
Amount recalled
653,280 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

Tubing detachment

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 16, 2016 · Data as of Sep 19, 5:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.