ClearanceBrief
Recall Z-0518-2014 ยท CAZ Anesthesia Conduction Kit

Kimberly-Clark Corporation

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

DateDec 16, 2013 (initiated Oct 24, 2013)
StatusTerminated
ReasonKimberly-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.
Root causeComponent design/selection
ActionKimberly 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
Quantity389,300 units
DistributionU.S. Nationwide Distribution
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K941153EPI-SPINAL ANESTHESIA TRAY
Preferred Medical Products, May 30, 1995