Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
FDA device recall Z-2324-2025 · posted 2025-08-14 · Open, Classified
Recall details
- Recalling firm
- Diversatek Healthcare
- 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.
- Action taken
- On 6/4/2025, field safety notices were emailed to GI Lab / Endoscopy Unit Managers who were asked to do the following: Check your inventory for devices with the part and lot numbers listed below. 2. Discard any affected product. 3. Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE form via email to clahr@diversatek.com If you have questions about this issue, please contact your Sales Representative or the firm at 1-800-558-6408
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- FFX
- Quantity affected
- 8
- Distribution
- Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
- Date initiated
- 2025-06-04
- Date posted
- 2025-08-14
- Location
- Highlands Ranch, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (K190208) | Diversatek Healthcare | 2019-10-03 |