Z-2467-2012 Class II Terminated
FDA device recall Z-2467-2012 was initiated by Mc-NEIL-PPC, Inc. on July 2, 2012 and is designated Class II. 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 … The recall status is terminated (terminated September 27, 2013). Affected quantity: 818,712.
Recall Details
- Product Type
- Devices
- Report Date
- October 3, 2012
- Initiation Date
- July 2, 2012
- Termination Date
- September 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 818,712
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
Distribution Pattern
Nationwide Distribution
Code Information
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.