Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Reported: October 5, 2022 Initiated: July 21, 2022 #Z-1810-2022
Product Description
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Reason for Recall
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.
Details
- Recalling Firm
- Unomedical A/S
- Units Affected
- 1,643,320 units
- Distribution
- Distribution was made to California. There was no government/military distribution.
- Location
- LEJRE, N/A
Frequently Asked Questions
What product was recalled? ▼
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.. Recalled by Unomedical A/S. Units affected: 1,643,320 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2022. Severity: Moderate. Recall number: Z-1810-2022.
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