Recall Z-2324-2025
Diversatek Healthcare · initiated June 4, 2025
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Codes / lots: UDI-DI: 00816734022863, Lot: 24752
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.
FDA-determined cause: Error in labeling
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
Details
- Recall number
- Z-2324-2025
- Initiated
- June 4, 2025
- Posted by FDA
- August 14, 2025
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Quantity
- 8
- Distribution
- Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
- Recalling firm
- Diversatek Healthcare, Highlands Ranch, CO