Reported Nov 9, 2016 · Terminated

Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact…

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?

7 of 7 products

Products covered by this recall
#Product as published
1Contact Detach, 8mm, 23", G29
2Contact Detach 8 mm, 43", G29
3Contact Detach, 6mm, 23" G29
4Infusion Set, Contact Detach, 6mm x 23"
5Infusion Set, Contact Detach, 6mm x 32"
6Infusion Set, Contact Detach, 8mm x 23"
7Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Lot codes and dates
  • 71 of 71 codes

    • 5031810
    • 5034061
    • 5034232
    • 5035097
    • 5036348
    • 5038182
    • 5038183
    • 5038184
    • 5038185
    • 5038186
    • 5038187
    • 5038188
    • 5040990
    • 5040991
    • 5040992
    • 5041073
    • 5041074
    • 5045147
    • 5045148
    • 5047241
    • 5047242
    • 5047243
    • 5047245
    • 5048097
    • 5053689
    • 5054465
    • 5054466
    • 5054550
    • 5054553
    • 5054554
    • 5057103
    • 5057104
    • 5057105
    • 5057106
    • 5058633
    • 5058637
    • 5058731
    • 5058732
    • 5058733
    • 5058734
    • 5062769
    • 5062770
    • 5062780
    • 5062811
    • 5062812
    • 5062813
    • 5066512
    • 5066999
    • 5067219
    • 5067220
    • 5067221
    • 5067222
    • 5067223
    • 5067224
    • 5067225
    • 5067226
    • 5067574
    • 5068464
    • 5068465
    • 5071889
Amount recalled
664,000 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.

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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, 4:45 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.