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U.S. Department of Health and Human Services

Class 2 Device Recall Revive Reusable Bladder Support

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  Class 2 Device Recall Revive Reusable Bladder Support see related information
Date Initiated by Firm May 02, 2019
Create Date July 09, 2019
Recall Status1 Terminated 3 on November 12, 2019
Recall Number Z-1952-2019
Recall Event ID 83023
510(K)Number K183468  
Product Classification Pessary, vaginal - Product Code HHW
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.
Code Information Lot 75770223
Recalling Firm/
Manufacturer
Rinovum Women's Health
300 Oxford Dr Ste 330
Monroeville PA 15146-2361
For Additional Information Contact joyceanne Rylander
412-200-7996
Manufacturer 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 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HHW and Original Applicant = Rinovum Subsidiary 2, LLC
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