Reported Nov 9, 2016 · Terminated

Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC#…

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?

4 of 4 products

Products covered by this recall
Model / numberProduct as published
3-89110-14147-7Comfort 5+5 Pack w/110cm Tube & 17mm Cann.
3-89110-14127-9Comfort 5+5 Pack w/60cm Tube & 17mm Cann.
3-89110-14143-9Comfort 5+5 Pack w/110cm Tube & 13mm Cann.
3-89110-14123-1Conform 5+5 Pack w/60cm Tube & 13mm Cann. The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Lot codes and dates
    • 5048997
    • 5048998
    • 5048999
    • 5052118
    • 5052332
    • 5052333
    • 5052334
    • 5063721
    • 5066962
    • 5066963
    • 5066964
Amount recalled
22,114 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.