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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow OTW Percutaneous Thrombolytic Device (PTD)

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  Class 2 Device Recall Arrow OTW Percutaneous Thrombolytic Device (PTD) see related information
Date Initiated by Firm February 11, 2009
Date Posted June 24, 2009
Recall Status1 Terminated 3 on July 22, 2010
Recall Number Z-1502-2009
Recall Event ID 51887
510(K)Number K011056  
Product Classification Percutaneous Thrombolytic Device - Product Code DXE
Product Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts
Code Information All lots of Product codes listed in Z-1489-2009.
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading PA 19605
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

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 = ARROW INTL., INC.
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