Summary
The FDA issued a Class III for Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 by Diversatek Healthcare. Reason: Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the exp.
Details
Source
Device Recall
External ID
Z-2324-2025
Action Date
2025-08-20
Status
Ongoing
Category
device
Product Description
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Lot/Code Info: UDI-DI: 00816734022863, Lot: 24752
Quantity Affected: 8
Reason for Recall
Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
Distribution
Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-04
Company
Highlands Ranch, CO
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 169 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Diversatek Healthcare has 8 FDA actions in our database, including 7 recalls and 1 clearance.
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 (Diversatek Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Diversatek Healthcare have FDA actions?
Diversatek Healthcare has 8 FDA actions in our database, including 7 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2324-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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