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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 Catheterssee related information
Date Initiated by FirmMarch 25, 2009
Date PostedJune 25, 2009
Recall Status1 Terminated 3 on February 01, 2010
Recall NumberZ-1471-2009
Recall Event ID 51960
510(K)NumberK902327 
Product Classification Catheter, embolectomy - Product Code DXE
ProductArrow 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/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information ContactJody Cadd
610-378-0131
Manufacturer Reason
for Recall
The inflation arm tubing may separate from the stopcock adapter.
FDA Determined
Cause 2
Process control
ActionArrow 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 Commerce6910 units (total all three products)
DistributionWorldwide Distribution - USA and Panama.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DXE
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