Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac
Summary
The FDA issued a Class II for Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and In by Ohio Medical Corporation. Reason: Increase in premature device failures.
Details
Source
Device Recall
External ID
Z-0482-2022
Action Date
2022-01-19
Status
Ongoing
Category
device
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.
Lot/Code Info: Shipped between March 2019 and February 2021.
Quantity Affected: 649 portable suction pumps and replacement pumps
Reason for Recall
Increase in premature device failures
Distribution
US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-16
Company
Gurnee, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 106 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ohio Medical Corporation has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ohio Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ohio Medical Corporation have FDA actions?
Ohio Medical Corporation has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0482-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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