FDAMarch 5, 2024device
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
What to do
FDA enforcement status: Ongoing
Brands named
unomedical a sunomedical
UPCs
05705244001558
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
- 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
- FDASure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.2015-05-21
- 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
- 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
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