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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Nerve Block Component, Product Code: AB18040N

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  Class 2 Device Recall Arrow Nerve Block Component, Product Code: AB18040N see related information
Date Initiated by Firm November 10, 2014
Date Posted December 12, 2014
Recall Status1 Terminated 3 on September 08, 2016
Recall Number Z-0573-2015
Recall Event ID 69740
510(K)Number K121403  
Product Classification Anesthesia conduction kit - Product Code CAZ
Product Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or
analgesia techniques for periods not exceeding 72 hours.
Code Information Product Number: AB-18040-N;  Lot Number:  RF2096425,  RF2010131,  RF1057898,  RF0074365,  RF0035689 
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 is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported.
FDA Determined
Cause 2		 Labeling False and Misleading
Action An urgent medical device recall notification, dated November 11, 2014, was sent to consignees which identified the product, problem, and action to be taken. Customers with affected stock were asked to immediately discontinue use and quarantine any products with the catalog and lot number. To return product, the Recall Acknowledgement Form should be completed and faxed to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will be in contact to provide instructions for the return of product. All customers were asked to complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com.
Quantity in Commerce 786
Distribution US 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 = TELEFLEX, INC.
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