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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Super ArrowFlex(R) Percutaneous Sheath Introducer Set

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  Class 2 Device Recall Arrow Super ArrowFlex(R) Percutaneous Sheath Introducer Set see related information
Date Initiated by Firm December 20, 2010
Date Posted January 21, 2011
Recall Status1 Terminated 3 on September 25, 2014
Recall Number Z-0936-2011
Recall Event ID 57572
510(K)Number K780532  
Product Classification Introducer, catheter - Product Code DYB
Product Super Arrow-Flex(R) PSI Set

Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures
Code Information Part No: CL-07645, Lot No: CF0014630
Recalling Firm/
Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Customer Support
610-378-0131 Ext. 3318
Manufacturer Reason
for Recall
Packaging may have been compromised, and sterility of product cannot be guaranteed.
FDA Determined
Cause 2
Action The firm, Teleflex Medical thru its subsidiary Arrow International, Inc., sent an "Urgent Field Safety Notice" letter dated December 20, 2010, with Field Acknowledgement form to all customers. The letter described the product, problem and action to be taken by the customers. The letter instructed the customers to check their stock for affected product, cease use and distribution of product and quarantine all products from affected lot immediately; contact their local Teleflex Medical Customer Service/Sales Rep (or Distributor) for a return authorization number prior to filling out the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM; and complete and return the form immediately by email. If you do not have the product from the affected lot, indicate it on the form and fax it to your local Teleflex Medical Customer Service/Sales Rep (or Distributor). The Teleflex Medical Customer Service/Sales Rep (or Distributor) will coordinate the product return with the customer. If you have any questions, please contact the Regulatory Affairs Project Manager at 610-378-0131 ext 3318 or email: Jody.Cadd@teleflexmedical.com.
Quantity in Commerce 320 units
Distribution International distribution only: countries include: Austria, Belgium, Czech Republic, Germany, Greece, Italy, and Luxembourg.
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 = DYB and Original Applicant = ARROW INTL., INC.