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.
FDA Recall Z-0482-2022 · Posted None
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Recalling FirmOhio Medical Corporation
Recall StatusOpen, Classified
Product CodeBTA
Date Initiated2021-11-16
Product Quantity649 portable suction pumps and replacement pumps
Reason for Recall
Increase in premature device failures
Firm Action
The firm notified their consignees by letter beginning 11/16/2021 via USPS. The letter identified the defect and requested the return of the affected devices for testing unless it is not feasible to do so. Consignees were provided an alternative option for on site testing if the device could not be returned.
Root Cause
Employee error
Distribution Pattern
US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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