Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Reported: August 20, 2025 Initiated: June 4, 2025 #Z-2324-2025
Product Description
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
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.
Details
- Recalling Firm
- Diversatek Healthcare
- Units Affected
- 8
- Distribution
- Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
- Location
- Highlands Ranch, CO
Frequently Asked Questions
What product was recalled? ▼
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10. Recalled by Diversatek Healthcare. Units affected: 8.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2025. Severity: Low. Recall number: Z-2324-2025.
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