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
This recall has been terminated (originally issued December 16, 2013).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- October 24, 2013
- Posted
- December 16, 2013
- Terminated
- August 25, 2017
- Recall Number
- Z-0518-2014
- Quantity
- 389,300 units
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
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
U.S. Nationwide Distribution
Lot / Code Info
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).
Root Cause
Component design/selection
Action Taken
Kimberly Clark Corporation sent a Product Advisory Notice letter to affected consignees. The letter identified the affected product, problem and actions to be taken. For questions call 770-587-8393 or via email