FDA recall Z-1810-2022

Product

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.

Distribution

Distribution was made to California. There was no government/military distribution.

Key facts

Status

Terminated

Initiation date

2022-07-21

Report date

2022-10-05

Termination date

2026-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

LEJRE, N/A, Denmark

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1810-2022