Enforcement Report - Week of October 3, 2012
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Product Detail
| Product Description | KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant |
|---|---|
| Recall Number | Z-2467-2012 |
| Classification | Class II |
| Code Info | The following Lot Numbers were identified: 2721W; 2591W; 2321W; 1681W; 0921W; 0651W; 0471W; 0361W; 0221W; 0041W; 0110H; 0100H; 0090H; 0080H; 0030H; 0179H; 0159H; 0219H and 3489RT. |
| Product Distributed Qty | 818,712 |
| Reason For Recall | Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that this device, KY Liquibeads Vaginal Moisturizer, is misbranded under the section 502(o) the Act, 21 U.S.C. 352(o), because we did not notify the agency of our intent to introduce the device into commercial distribution, as required by 510(k) of the Act, U.S.C. 360(k). The Warning Letter indicated that changes were made to the predicate device that would require submission of a new 510(k). |
Event Detail
| Event Id | 62948 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Mc-NEIL-PPC, Inc. |
| City | Skillman |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-02 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution |
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