Recall Z-1952-2019
Rinovum Women's Health · initiated May 2, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot 75770223
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).
FDA-determined cause: Process change control
Action taken
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.
Details
- Recall number
- Z-1952-2019
- Initiated
- May 2, 2019
- Terminated
- November 12, 2019
- Product code
- HHW – Pessary, Vaginal
- Quantity
- 1024 (180 distributed from distributor)
- Distribution
- US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.
- Recalling firm
- Rinovum Women's Health, Monroeville, PA