|
Class 2 Device Recall KimberlyClark Single Shot Epidural Pain Management Trays |
|
Date Initiated by Firm |
October 24, 2013 |
Date Posted |
December 16, 2013 |
Recall Status1 |
Terminated 3 on August 25, 2017 |
Recall Number |
Z-0518-2014 |
Recall Event ID |
66859 |
510(K)Number |
K941153
|
Product Classification |
Anesthesia conduction kit - Product Code CAZ
|
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
|
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). |
Recalling Firm/ Manufacturer |
Kimberly-Clark Corporation 1400 Holcomb Bridge Rd Roswell GA 30076-2190
|
For Additional Information Contact |
Thomas Kozma, PhD 770-587-8393
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = CAZ and Original Applicant = PREFERRED MEDICAL PRODUCTS
|
|
|
|