| 2024-07-23 |
Class II
|
Ongoing |
Z-3186-2024 |
VariSoft Infusion Set, Single Use. |
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Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set". |
| 2024-03-05 |
Class II
|
Ongoing |
Z-1544-2024 |
Neria Soft Infusion Set, Product Code 507302, intravascular administration set |
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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… |
| 2023-10-11 |
Class I
|
Ongoing |
Z-0234-2024 |
VariSoft infusion set, Model Number 1002830 |
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The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This dam… |
| 2023-10-11 |
Class I
|
Ongoing |
Z-0233-2024 |
VariSoft infusion set, Model Number 1002828 |
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The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This dam… |
| 2023-10-11 |
Class I
|
Ongoing |
Z-0232-2024 |
VariSoft infusion set, Model Number 1002827 |
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The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This dam… |
| 2022-07-21 |
Class II
|
Terminated |
Z-1810-2022 |
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusio… |
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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. |