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Rinovum Women's Health recalls Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary ma
Recalled July 17, 2019 · FDA recall Z-1952-2019 · Rinovum Women's Health
Hazard
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). · FDA Class II
Units
1024 (180 distributed from distributor)
Sold at
US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.
Description
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).
Product
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.
Manufacturer(s)
Rinovum Women's Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →