Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
This recall is currently active, issued August 14, 2025. It was issued by Diversatek Healthcare.
- Company
- Diversatek Healthcare
- Recall Initiated
- June 4, 2025
- Posted
- August 14, 2025
- Recall Number
- Z-2324-2025
- Quantity
- 8
- Firm Location
- Highlands Ranch, CO
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
Lot / Code Info
UDI-DI: 00816734022863, Lot: 24752
Root 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