Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and applicator, and disposable strings and travel case. The device is nonperishable and does not have an expiration date.
FDA Recall Z-1952-2019 · Posted None
Advertisement
Recalling FirmRinovum Women's Health
Recall StatusTerminated
Product CodeHHW
Date Initiated2019-05-02
Date Terminated2019-11-12
Product Quantity1024 (180 distributed from distributor)
Reason for Recall
The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).
Firm Action
The firm began notifying affected retailers of the recall starting May 9, 2019.
Retailers were asked to do the following:
- Immediately remove affected product
-Complete the verification form
-File a claim against supplier and return the merchandise to the manufacturer
Store questions may be directed to the Compliance Hotline at 700-925-6278.
Root Cause
Process change control
Distribution Pattern
US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement