| Class 2 Device Recall Arrow Embolectomy Catheters | |
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
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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/ Manufacturer |
Arrow International Inc 2400 Bernville Road Reading PA 19605
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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 |
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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
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