Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall see related information
Date Initiated by Firm January 08, 2003
Date Posted February 28, 2003
Recall Status1 Terminated 3 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
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 2		 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.
-
-