Z-0873-2013 Class II Terminated

Recalled by Mc-NEIL-PPC, Inc. — Skillman, NJ

FDA device recall Z-0873-2013 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: 1,185,664 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
1,185,664 units

Product Description

KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, 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

Tube UPC: 380040085503 Case Code(s): 008550 V21, 008550 V00 Outer case UPC Code: 103800400855000215 Outer case UPC Code: 103800400855000000 Outer case Display UPC Code: 00380041153300