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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses
Recall Number Z-0542-2014
Classification Class II
Code Info Lot 361950571720, potential incorrect expiry date 1/2018; Lot 361950575934, potential incorrect expiry date 9/2017; Lot 361950589008, potential incorrect expiry date 2/2018; Lot 361950590915, potential incorrect expiry date 8/2018; Lot 361950597210, potential incorrect expiry date 7/2017; Lot 361950599011, potential incorrect expiry date 8/2018; Lot 361950599816, potential incorrect expiry date 9/2017; Lot 361950606714, potential incorrect expiry date 12/2017; Lot 361950608721, potential incorrect expiry date 6/2018; Lot 361950613813, potential incorrect expiry date 1/2018; Lot 361950632507, potential incorrect expiry date 3/2018; Lot 361950638202, potential incorrect expiry date 2/2017; Lot 361950644719, potential incorrect expiry date 10/2018; Lot 361950646326, potential incorrect expiry date 10/2018; Lot 361950647128, potential incorrect expiry date 10/2018; Lot 361950676608, potential incorrect expiry date 12/2018; Lot 361950682615, potential incorrect expiry date 10/2017; Lot 361950684220, potential incorrect expiry date 10/2019; Lot 361950691505, potential incorrect expiry date 1/2017; Lot 361950692806, potential incorrect expiry date 7/2018; Lot 361950706108, potential incorrect expiry date 12/2018; Lot 361950706308, potential incorrect expiry date 1/2015; Lot 361950711903, potential incorrect expiry date 7/2018; Lot 361950712707, potential incorrect expiry date 2/2017; Lot 361950742714, potential incorrect expiry date 1/2017; Lot 361950744516, potential incorrect expiry date 10/2017; Lot 361950767118, potential incorrect expiry date 4/2018; Lot 361950778620, potential incorrect expiry date 1/2018; Lot 361950789608, potential incorrect expiry date 4/2018; Lot 361950800811, potential incorrect expiry date 3/2017; Lot 361950826215, potential incorrect expiry date 3/2018; Lot 361950829333, potential incorrect expiry date 9/2017; Lot 361950839008, potential incorrect expiry date 4/2017; Lot 361950845916, potential incorrect expiry date 3/2018; Lot 361950859017, potential incorrect expiry date 3/2017; Lot 361950863106, potential incorrect expiry date 9/2017; Lot 361950894913, potential incorrect expiry date 1/2018; Lot 361950912828, potential incorrect expiry date 6/2018; Lot 361950919611, potential incorrect expiry date 4/2018; Lot 361950919914, potential incorrect expiry date 4/2018; Lot 361950937619, potential incorrect expiry date 5/2018; Lot 361950955510, potential incorrect expiry date 7/2013, 8/2018; Lot 361950955610, potential incorrect expiry date 3/2018; Lot 361950971611, potential incorrect expiry date 4/2018; Lot 361950972311, potential incorrect expiry date 8/2018, 8/2013; Lot 361951007612, potential incorrect expiry date 7/2017; Lot 361951028930, potential incorrect expiry date 2/2018; Lot 361951041224, potential incorrect expiry date 2/2018; Lot 361951053705, potential incorrect expiry date 7/2018; Lot 361951057108, potential incorrect expiry date 7/2018.
Product Distributed Qty 153 cartons
Reason For Recall Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.

Event Detail

Event Id 66844
Product Type Devices
Status Ongoing
Recalling Firm CooperVision Inc.
City W Henrietta
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
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