Summary
The FDA issued a Class II for 8mm FlexDex Needle Driver, Product Code FD-335 ND by FlexDex Inc.. Reason: The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, inc.
Details
Source
Device Recall
External ID
Z-0531-2022
Action Date
2022-02-02
Status
Terminated
Category
device
Product Description
8mm FlexDex Needle Driver, Product Code FD-335 ND
Lot/Code Info: All lots
Quantity Affected: 273
Reason for Recall
The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-22
Company
Brighton, MI
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 97 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (FlexDex Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FlexDex Inc. have FDA actions?
This is the only FDA action we have on record for FlexDex Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0531-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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