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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-1471-2009
Recall Event ID 51960
510(K)Number K902327  
Product Classification Catheter, embolectomy - Product Code DXE
Product Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, 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: CF8024537, CF8035837, CF8036331, CF8036759, CF8047807, CF8059710, CF8060585, CF8062240, CF8072762, CF8074445, CF7084561, CF8096988, CF8097442, CF8097705, CF8100439, CF8109029, CF8109961, CF8110887, CF8111320, CF8111840 and CF8112312.
Recalling Firm/
Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Jody Cadd
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.