Skip to content
Recall Observatory FDA recall evidence

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

November 16, 2021

Class II

Product summary

Firm
Ohio Medical Corporation
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

    reason.no_named_rule · v1.0.0

    Increase in premature device failures