FDAJuly 21, 2022device
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
What to do
FDA enforcement status: Terminated
Brands named
unomedical a sunomedical
UPCs
05705244018129
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 10028302023-10-11
- FDAVariSoft infusion set, Model Number 10028272023-10-11
- FDAVariSoft infusion set, Model Number 10028282023-10-11
- 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
- FDASureT 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 in combination wi...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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