Z-1952-2019 Class II Terminated
FDA device recall Z-1952-2019 was initiated by Rinovum Women's Health on May 2, 2019 and is designated Class II. 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). The recall status is terminated (terminated November 12, 2019). Affected quantity: 1024 (180 distributed from distributor).
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2019
- Initiation Date
- May 2, 2019
- Termination Date
- November 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1024 (180 distributed from distributor)
Product Description
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 Pattern
US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.
Code Information
Lot 75770223