Z-0874-2013 Class II Terminated
FDA device recall Z-0874-2013 was initiated by Mc-NEIL-PPC, Inc. on January 25, 2013 and is designated Class II. Reason for recall: This product is not cleared for marketing in the US. The recall status is terminated (terminated April 11, 2014). Affected quantity: 750,264 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2013
- Initiation Date
- January 25, 2013
- Termination Date
- April 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 750,264 units
Product Description
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.
Reason for Recall
This product is not cleared for marketing in the US.
Distribution Pattern
Nationwide Distribution.
Code Information
Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300