Class 2 Device Recall

• Date Initiated by Firm: January 08, 2003
• Date Posted: February 28, 2003
• Recall Status: Terminated on May 03, 2012
• Recall Number: Z-0602-03
• Recall Event ID: 25401
• Product: Bard Orbiter ST Artrial Mapping Steerable Catheter Item Numbers 320001 7FAM00001 7FAM00010 7FAM00019 7FAM0008B 7FAM0017B 320002 7FAM00002 7FAM00011 7FAM00020 7FAM0009B 7FAM0018B 320003 7FAM00003 7FAM00012 7FAM0001B 7FAM0010B 7FAM0019B 320004 7FAM00004 7FAM00013 7FAM0002B 7FAM0011B 7FAM0020B 320005 7FAM00005 7FAM00014 7FAM0003B 7FAM0012B 320006 7FAM00006 7FAM00015 7FAM0004B 7FAM0013B 320007 7FAM00007 7FAM00016 7FAM0005B 7FAM0014B 320008 7FAM00008 7FAM00017 7FAM0006B 7FAM0015B 320009 7FAM00009 7FAM00018 7FAM0007B 7FAM0016B
• Code Information: All lot numbers were the 4th digit contains the letter A through M. Ex. 07A''A''1234
• FEI Number: 1000120754
• Recalling Firm/ Manufacturer: C. R.Bard, Inc./Electrophysiology Division; 129 Concord Road; Billerica MA 01821
• For Additional Information Contact: Chris O. Fappiano; 978-323-2230
• Manufacturer Reason for Recall: Sterile barrier maybe perforated compromising sterility of the device
• FDA Determined Cause: Packaging process control
• Action: Bard Electrophysiology notified direct accounts by letter on 1.08.03 via Fed''X. Accounts are requested to return product.
• Quantity in Commerce: 6784 units
• Distribution: Nationwide

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.