FDA recall Z-1952-2019

Rinovum Women's Health · Class II · device

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.

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).

Distribution

US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.

Key facts

Status
Terminated
Initiation date
2019-05-02
Report date
2019-07-17
Termination date
2019-11-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monroeville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1952-2019