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U.S. Department of Health and Human Services

Class 2 Device Recall KY LIQUIBEADS Vaginal Moisturizer

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  Class 2 Device Recall KY LIQUIBEADS Vaginal Moisturizer see related information
Date Initiated by Firm July 02, 2012
Date Posted September 27, 2012
Recall Status1 Terminated 3 on September 27, 2013
Recall Number Z-2467-2012
Recall Event ID 62948
Product Classification Lubricant, patient, vaginal, latex compatible - Product Code NUC
Product KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958.

Personal lubricant
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.
Recalling Firm/
Manufacturer		 Mc-NEIL-PPC, Inc.
199 Grandview Rd
Skillman NJ 08558-1311
For Additional Information Contact Stericycle
908-874-1000
Manufacturer 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
FDA Determined
Cause 2		 No Marketing Application
Action Johnson & Johnson sent Recall Letters/Response forms dated June 29, 2012 on July 2, 2012. The recall notification included affected lots and instructions for wholesale distributors and retailers that handle the product. The recalled product is being handled by Stericycle. The notification included phone and fax numbers in the event assistance is required. Customers were asked to complete the enclosed business Reply Form and return immediately; identify all warehouse/wholesale inventories of products and return immediately per the attached "Return Authorization Form." For any questions regarding the form, customers were asked to call Stericycle at 888-406-9309. Customers could also fax questions to 877-877-0318. Once customers have collected all returns, they should send back immediately per the enclosed instructions. For questions regarding this recall call 908-874-1000.
Quantity in Commerce 818,712
Distribution Nationwide Distribution
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.
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