Z-0482-2022 Class II Ongoing

Recalled by Ohio Medical Corporation — Gurnee, IL

Recall Details

Product Type
Devices
Report Date
January 19, 2022
Initiation Date
November 16, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
649 portable suction pumps and replacement pumps

Product Description

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 Pattern

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

Code Information

Shipped between March 2019 and February 2021.