Zvu Anorectal Manometry Procedure Kit recall: Labeling Error
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Why was Zvu Anorectal Manometry Procedure Kit recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00816734022863, Lot: 24752
- Product
- Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
- Recalling firm
- Diversatek Healthcare
- Quantity
- 8
- Distribution
- Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
- Recall date
- August 20, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)