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U.S. Department of Health and Human Services

Class 2 Device Recall Instavac

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 Class 2 Device Recall Instavacsee related information
Date Initiated by FirmNovember 16, 2021
Create DateJanuary 11, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0482-2022
Recall Event ID 88984
510(K)NumberK933902 
Product Classification Pump, portable, aspiration (manual or powered) - Product Code BTA
ProductInstavac 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.
Code Information Shipped between March 2019 and February 2021.
Recalling Firm/
Manufacturer		 Ohio Medical Corporation
1111 Lakeside Dr
Gurnee IL 60031-2489
For Additional Information ContactCustomer Service
800-448-0770
Manufacturer Reason
for Recall		Increase in premature device failures
FDA Determined
Cause 2		Employee error
ActionThe 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.
Quantity in Commerce649 portable suction pumps and replacement pumps
DistributionUS Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BTA
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