Z-0518-2014 Class II Terminated
FDA device recall Z-0518-2014 was initiated by Kimberly-Clark Corporation on October 24, 2013 and is designated Class II. Reason for recall: 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 tra… The recall status is terminated (terminated August 25, 2017). Affected quantity: 389,300 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2013
- Initiation Date
- October 24, 2013
- Termination Date
- August 25, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 389,300 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
U.S. Nationwide Distribution
Code Information
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).