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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow International, Inc. ASK05501AFH1

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  Class 2 Device Recall Arrow International, Inc. ASK05501AFH1 see related information
Date Initiated by Firm September 15, 2014
Date Posted October 22, 2014
Recall Status1 Terminated 3 on December 18, 2015
Recall Number Z-0114-2015
Recall Event ID 69256
510(K)Number K001587  
Product Classification Anesthesia conduction kit - Product Code CAZ
Product ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
Code Information Catalog No. ASK-05501-AFH1  Lot Number 23F13K0969
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Customer Support
610-378-0131
Manufacturer Reason
for Recall		 Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, Glass.
FDA Determined
Cause 2		 Labeling mix-ups
Action Arrow International sent a Medical Device Advisory Notification dated September 15, 2014, to affected customers notifying them that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component, and requesting they provide this Advisory Notice to all those who need to be aware of it within your organization. Questions were directed to local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 300
Distribution US Distribution in Utah only.
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 = ARROW INTL., INC.
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