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U.S. Department of Health and Human Services

Class 2 Device Recall KimberlyClark Single Shot Epidural Pain Management Trays

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 Class 2 Device Recall KimberlyClark Single Shot Epidural Pain Management Trayssee related information
Date Initiated by FirmOctober 24, 2013
Date PostedDecember 16, 2013
Recall Status1 Terminated 3 on August 25, 2017
Recall NumberZ-0518-2014
Recall Event ID 66859
510(K)NumberK941153 
Product Classification Anesthesia conduction kit - Product Code CAZ
ProductKimberly-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).
FEI Number 1000015879
Recalling Firm/
Manufacturer		 Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076-2190
For Additional Information ContactThomas 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
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
Quantity in Commerce389,300 units
DistributionU.S. Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CAZ
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