| Class 2 Device Recall Arrow Percutaneous Sheath Introducers | |
Date Initiated by Firm | February 11, 2009 |
Date Posted | June 24, 2009 |
Recall Status1 |
Terminated 3 on July 22, 2010 |
Recall Number | Z-1493-2009 |
Recall Event ID |
51887 |
510(K)Number | K781846 |
Product Classification |
sheath introducer - Product Code KGZ
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Product | Arrow Percutaneous Sheath Introducers |
Code Information |
All lots of Product codes listed in Z-1489-2009. |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Road Reading PA 19605
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For Additional Information Contact | Customer Service Department 800-523-8446 |
Manufacturer Reason for Recall | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. |
FDA Determined Cause 2 | Device Design |
Action | Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism. |
Quantity in Commerce | 900,000 total, all products |
Distribution | Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela. |
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 = KGZ
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