Recall Z-2324-2025— Diversatek Healthcare
Class III · Ongoing
Class III FDA medical device recall by Diversatek Healthcare, initiated 2025-06-04. It names one FDA 510(k) clearance: K190208. Product: Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10. Reason: 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..
- Recalling firm
- Diversatek Healthcare
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2025-06-04
- Firm location
- Highlands Ranch, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.