Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Numb
Summary
The FDA issued a Class III for Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/c by Medical Action Industries, Inc. 306. Reason: An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027..
Details
Source
Device Recall
External ID
Z-0069-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A
Lot/Code Info: Lot Code: Lot Number: 333606 UDI: 20809160118228 Expiration Date: 3/31/2027
Quantity Affected: 4000
Reason for Recall
An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
Distribution
U.S.: CA O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-09
Company
Arden, NC
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Medical Action Industries, Inc. 306 has 14 FDA actions in our database, including 14 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Medical Action Industries, Inc. 306) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medical Action Industries, Inc. 306 have FDA actions?
Medical Action Industries, Inc. 306 has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0069-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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