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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 66859
Product Type Devices
Status Ongoing
Recalling Firm Kimberly-Clark Corporation
City Roswell
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-24
Initial Firm Notification of
Consignee or Public
Distribution Pattern U.S. Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs Lot numbers: 181024, 181129 181217, 181221, 181231, 182022, 182058, 182101, 182108, 182131, 182222, 182223, 182263, 182265, 182289, 182293, 182301, 182315, 181A074, 181A94, 181A154, 181A177, 181A286, 181A289, 181A369, 182A002, 182A005, 182A012, 182A055, 182A056, 182A057, 182A064, 182A074, 182A075/182A78, 182A085, 182090, 182A142, 182AA144, 182A151, 182A155, 182A178, 182A194, 182A196, 182A198, 182A202, 182A204, 182A212, 182A216 and 189A001 (syringe). Class II Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe. 389,300 units Z-0518-2014