FDA recall Z-0482-2022

Product

Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.

Reason for recall

Increase in premature device failures

Distribution

US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.

Key facts

Status

Ongoing

Initiation date

2021-11-16

Report date

2022-01-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0482-2022