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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Embolectomy Catheters

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  Class 2 Device Recall Arrow Embolectomy Catheters see related information
Date Initiated by Firm March 25, 2009
Date Posted June 25, 2009
Recall Status1 Terminated 3 on February 01, 2010
Recall Number Z-1473-2009
Recall Event ID 51960
510(K)Number K902327  
Product Classification Catheter, embolectomy - Product Code DXE
Product Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605.

The arterial embolectomy catheter is intended for use in removing arterial emboli.
Code Information Lot Numbers: CF8036225, CF8036752, CF8059712, CF8061821, CF8084535, F8096770, CF8098599, CF8109960, CF8111317 and CF8112749.
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Jody Cadd
610-378-0131
Manufacturer Reason
for Recall		 The inflation arm tubing may separate from the stopcock adapter.
FDA Determined
Cause 2		 Process control
Action Arrow International issued an "Urgent Medical Device Recall" letter dated March 25, 2009 describing proper handling of the affected device. Consignees were also instructed to complete a Recall Acknowledgement and Stock Status Form and fax to Arrow International at 1-800-343-2935. Further questions should be directed to Arrow International, Customer Service Department at 1-800-523-8446.
Quantity in Commerce 6910 units (total all three products)
Distribution Worldwide Distribution - USA and Panama.
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 = DXE and Original Applicant = CLINCAL INSTRUMENTS CORP.
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