Reported Jul 17, 2019 · Terminated
Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary…
Rinovum Women's Health
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Rinovum Women's Health · 300 Oxford Dr Ste 330 · Monroeville, PA · 15146-2361
Is this the product you have?
- Revive Reusable Bladder Support, Model No. 0025 -
- Product UsageThe 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
- Lot codes and dates
- Lot 75770223
- Amount recalled
- 1024 (180 distributed from distributor)
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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