Reported Nov 9, 2016 · Terminated

SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32",…

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?

9 of 9 products

Products covered by this recall
#Product as published
1SureT G29 6mm, 18", Paradigm
2SureT G29 6mm 23"
3SureT G29 6mm, 23", Paradigm
4SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm
5SureT G29 8mm, 23"
6SureT G29 8mm, 23", Paradigm
7SureT G29 8mm, 32"
8SureT G29 8mm, 32", Paradigm
9SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Lot codes and dates
  • 251 of 251 codes

    • 5038783
    • 5040464
    • 5042582
    • 5042584
    • 5043414
    • 5043415
    • 5046638
    • 5046639
    • 5047168
    • 5049122
    • 5052903
    • 5052904
    • 5056680
    • 5057219
    • 5057241
    • 5057953
    • 5060205
    • 5061496
    • 5063694
    • 5064402
    • 5068516
    • 5068555
    • 5071403
    • 5072333
    • 5073682
    • 5075554
    • 5076349
    • 5043121
    • 5044843
    • 5057215
    • 5064141
    • 5068515
    • 5035649
    • 5035690
    • 5039578
    • 5039579
    • 5039580
    • 5039581
    • 5040158
    • 5040159
    • 5040465
    • 5040466
    • 5040467
    • 5040468
    • 5042578
    • 5042580
    • 5042581
    • 5043094
    • 5043095
    • 5043100
    • 5043106
    • 5043387
    • 5043417
    • 5043418
    • 5043419
    • 5046393
    • 5046395
    • 5046396
    • 5046640
    • 5046641
Amount recalled
4,748,000 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.

Want the full recall guide?

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

Free recall alerts

Get alerted about new Unomedical As recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 6:15 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.