Recall Z-2467-2012— Mc-NEIL-PPC, Inc.
Class II · Terminated
Class II FDA medical device recall by Mc-NEIL-PPC, Inc., initiated 2012-07-02, terminated 2013-09-27. FDA's recall record names no specific 510(k) clearance for this event. Product: KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant. Reason: 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 thi.
- Recalling firm
- Mc-NEIL-PPC, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-02
- Terminated
- 2013-09-27
- Firm location
- Skillman, NJ, United States
Product description
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
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 thi
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