Recall Z-1952-2019— Rinovum Women's Health
Class II · Terminated
Class II FDA medical device recall by Rinovum Women's Health, initiated 2019-05-02, terminated 2019-11-12. It names one FDA 510(k) clearance: K183468. 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: 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)..
- Recalling firm
- Rinovum Women's Health
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-02
- Terminated
- 2019-11-12
- Firm location
- Monroeville, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.