Device 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.
Z-0482-2022
Product summary
- Event
- Event 88984
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 649 portable suction pumps and replacement pumps
- Official record key
device-enforcement:Z-0482-2022
Official wording
Reason: Increase in premature device failures
Code information: Shipped between March 2019 and February 2021.
Distribution pattern: US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
Derived failure modes
-
Unknown
Increase in premature device failures