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Z-0482-2022 Class II Ongoing

Recalled by Ohio Medical Corporation — Gurnee, IL

FDA device recall Z-0482-2022 was initiated by Ohio Medical Corporation on November 16, 2021 and is designated Class II. Reason for recall: Increase in premature device failures The recall status is ongoing. Affected quantity: 649 portable suction pumps and replacement pumps.

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.