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U.S. Department of Health and Human Services

Class 2 Device Recall Continuous Peropheral Nerve Block Catheter Kit and Set

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 Class 2 Recall
Continuous Peropheral Nerve Block Catheter Kit and Set
see related information
Date Posted December 19, 2013
Recall Status1 Open
Recall Number Z-0546-2014
Recall Event ID 66589
Premarket Notification
510(K) Number
K121403 
Product Classification Anesthesia Conduction Kit - Product Code CAZ
Product Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set 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-07200 Stimulator Adapter Cable with lot numbers: RF0059570, RF2069779, RF0088984, RF2108983, RF0128588, RF3052266, RF1071764.
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading, Pennsylvania 19605
For Additional Information Contact Customer Support
610-378-0131
Manufacturer Reason
for Recall
A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated October 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of listed affected products/lots you have in stock; return affected products, customer service representative will contact you with RGA# and instructions for the return of the product, and complete enclosed Recall Acknowledgement form and fax to 1-800-343-2935, Attn: Customer Service, even if you have not affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.
Quantity in Commerce 121
Distribution Worldwide distribution: US (nationwide) including states of: MA, LA, CA, GA, KS, TX, PA, NY, MO, WI, NJ, MS, CT, ID, AL, CO, and PR; and Singapore.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CAZ and Original Applicant = TELEFLEX, INC.
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