Recall Z-1952-2019 ยท HHW Pessary, Vaginal
Rinovum Women's Health
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
| Date | May 2, 2019 |
| Status | Terminated |
| Reason | 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). |
| Root cause | Process change control |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183468 | Revive Reusable Bladder Support Rinovum Subsidiary 2, LLC, Jan 25, 2019 |