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U.S. Department of Health and Human Services

Class 3 Device Recall Zvu Anorectal Manometry Procedure Kit

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 Class 3 Device Recall Zvu Anorectal Manometry Procedure Kitsee related information
Date Initiated by FirmJune 04, 2025
Date PostedAugust 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2324-2025
Recall Event ID 97282
510(K)NumberK190208 
Product Classification System, gastrointestinal motility (electrical) - Product Code FFX
ProductZvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Code Information UDI-DI: 00816734022863, Lot: 24752
Recalling Firm/
Manufacturer		 Diversatek Healthcare
9150 Commerce Center Cir Ste 500
Highlands Ranch CO 80129-1563
For Additional Information ContactLaura L. Boll
303-470-7020
Manufacturer 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 2		Error in labeling
ActionOn 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 in Commerce8
DistributionWorldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FFX
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