The Recall Desk

FDA (Devices) recall action 74242

Unomedical As recalled 6 products on 2016-11-09

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2016-11-09
Critical
0
Units
17,165,789

Why these products were recalled

Tubing detachment

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2016-11-09

    Unomedical Comfort 5+5 Insulin Infusion Pump Sets Recalled for Tubing Detachment

    Unomedical As is recalling 22,114 Comfort 5+5 insulin infusion pump sets because the tubing may detach. The recall covers products distributed in the US and internationally.

    Product
    Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used
    Category
    Distribution
    3 states
  • SevereFDA (Devices)··2016-11-09

    Unomedical AC TenderLink Insulin Infusion Tubing Recalled for Detachment Risk

    Unomedical As is recalling AC TenderLink insulin infusion tubing sets due to a risk of tubing detachment. The voluntary recall affects 653,280 units distributed in the US and internationally.

    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; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination wit
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2016-11-09

    Unomedical Recalls SureT G29 Insulin Infusion Pump Tubing Due to Detachment Risk

    Unomedical As is voluntarily recalling SureT G29 insulin infusion pump tubing because it may detach. The recall covers 4,748,000 units distributed in the US and internationally.

    Product
    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2016-11-09

    Unomedical Recalls Insulin Infusion Sets Due to Tubing Detachment Risk

    Unomedical As is voluntarily recalling 664,000 Contact Detach infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2016-11-09

    Unomedical Silhouette Insulin Infusion Tubing Recalled for Detachment Risk

    Unomedical As is recalling Silhouette and Silhouette Paradigm insulin infusion tubing due to a risk of tubing detachment. The recall affects approximately 9.8 million units distributed in the US and internationally.

    Product
    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2016-11-09

    Unomedical Comfort Infusion Sets Recalled for Tubing Detachment Risk

    Unomedical As is recalling 1.3 million Comfort infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 4
    Category
    Distribution
    3 states