FDANovember 7, 2014device
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 infusion pumps fo...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Tubing detachment
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 10028272023-10-11
- FDAVariSoft infusion set, Model Number 10028302023-10-11
- 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
- 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
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