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U.S. Department of Health and Human Services

Class 2 Device Recall KY SilkE Vaginal Moisturizer and Personal Lubricant

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  Class 2 Device Recall KY SilkE Vaginal Moisturizer and Personal Lubricant see related information
Date Initiated by Firm January 25, 2013
Date Posted February 22, 2013
Recall Status1 Terminated 3 on April 11, 2014
Recall Number Z-0874-2013
Recall Event ID 64322
Product Classification Lubricant, personal - Product Code NUC
Product KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
Code Information Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300 
Recalling Firm/
Manufacturer		 Mc-NEIL-PPC, Inc.
199 Grandview Rd
Skillman NJ 08558-1311
For Additional Information Contact Stericycle
866-201-9138
Manufacturer Reason
for Recall		 This product is not cleared for marketing in the US.
FDA Determined
Cause 2		 No Marketing Application
Action Johnson and Johnson Healthcare Products sent recall notification letters dated 1/25/2013 to its customers (retailers and wholesalers). The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to return all cases of affected product in their possession. The letter included delivery confirmation and a return packing slip, return authorization label and business reply card. Contact J & J Sales & Logistics at 866-912-8414 for questions regarding the return of affected product. Contact your J & J Sales & Logistics Company Sales Representative for questions about the product.
Quantity in Commerce 750,264 units
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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