FDAMay 21, 2015device
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
What to do
FDA enforcement status: Terminated
Brands named
unomedical asunomedical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAVariSoft Infusion Set, Single Use.2024-07-23
- FDANeria Soft Infusion Set, Product Code 507302, intravascular administration set2024-03-05
- FDAVariSoft infusion set, Model Number 10028282023-10-11
- FDAVariSoft infusion set, Model Number 10028302023-10-11
- FDAVariSoft infusion set, Model Number 10028272023-10-11
- FDAAutosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.2022-07-21
- FDAContact 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 combination with ...2014-11-07
- FDAInfusion 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 43", STD 5/5; Infu...2014-11-07
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