KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e
Summary
The FDA issued a Class II for KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter As by Pro-Dex Inc. Reason: Incorrect Unique Device Identifier/GTIN code was used on product..
Details
Source
Device Recall
External ID
Z-1391-2023
Action Date
2023-04-26
Status
Ongoing
Category
device
Product Description
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
Lot/Code Info: Reference Number: PDEC-1000-2 Part Number: A9671 Lot Numbers: K0C1B, K0D3P, K0E8T, K0FSD, K0HGV
Quantity Affected: 199 devices
Reason for Recall
Incorrect Unique Device Identifier/GTIN code was used on product.
Distribution
U.S. Nationwide distribution in the state of FL.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-14
Company
Irvine, CA
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 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Pro-Dex Inc has 3 FDA actions in our database, including 3 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 (Pro-Dex Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pro-Dex Inc have FDA actions?
Pro-Dex Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1391-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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