Recall Z-2324-2025 ยท FFX System, Gastrointestinal Motility (Electrical)
Diversatek Healthcare
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
| Date | Aug 14, 2025 (initiated Jun 4, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Error in labeling |
| Action | 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 |
| Quantity | 8 |
| Distribution | Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe Diversatek Healthcare, Oct 3, 2019 |