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Class 2 Device Recall Arrow Embolectomy Catheters |
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Date Initiated by Firm |
March 25, 2009 |
Date Posted |
June 25, 2009 |
Recall Status1 |
Terminated 3 on February 01, 2010 |
Recall Number |
Z-1472-2009 |
Recall Event ID |
51960 |
510(K)Number |
K902327
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Product Classification |
Catheter, embolectomy - Product Code DXE
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Product |
Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, 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: CF8025431, CF8036321, CF8036744, CF8047808, CF8059711, CF8061823, CF8072763, CF80845363, CF8085910, CF8096987, CF8097704, CF8098581, CF8100407, CF8109030 and CF8112750. |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Road Reading PA 19605
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For Additional Information Contact |
Jody Cadd 610-378-0131
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Manufacturer Reason for Recall |
The inflation arm tubing may separate from the stopcock adapter.
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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
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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.
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510(K) Database |
510(K)s with Product Code = DXE and Original Applicant = CLINCAL INSTRUMENTS CORP.
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