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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow ASK20608CMC StimuCath Continuous Nerve Block Kit

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  Class 2 Device Recall Arrow ASK20608CMC StimuCath Continuous Nerve Block Kit see related information
Date Initiated by Firm June 17, 2011
Date Posted July 29, 2011
Recall Status1 Terminated 3 on October 01, 2012
Recall Number Z-2894-2011
Recall Event ID 59113
510(K)Number K030937  
Product Classification Anesthesia Conduction Kit - Product Code CAZ
Product Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit.
Arrow International, Inc.

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 Lot # MF0126544
Recalling Firm/
Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Tracy Larish
Manufacturer Reason
for Recall
Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed.
FDA Determined
Cause 2
Action Arrow International, Inc. sent an "Urgent Medical Device Recall" letter dated June 17, 2011 to all affected customers. The letter describes the problem and provides recommendations including; quarantine affected product, return of product, and send an acknowledgement form back to manufacturer. For additional information call 800 233-3187.
Quantity in Commerce 95 kits
Distribution Nationwide Distribution including the state of North Carolina.
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 INTERNATIONAL, INC.