Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0518-2014Class II

Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198)

Kimberly-Clark Corporation / initiated 2013-10-24 / Terminated / root cause: design

Kimberly-Clark Corporation began a recall of Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0518-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Kimberly-Clark Corporation
Product
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
Product code
CAZ Anesthesia Conduction Kit
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.
Root cause tag
design
FDA root cause
Component design/selection
Action
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
Quantity in commerce
389,300 units
Distribution
U.S. Nationwide Distribution
Product codes and lots
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).

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0518-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0518-2014Class IITerminatedVoluntary: Firm initiated