• 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-0603-03
Recall Event ID 25401
Product Bard Orbiter PV Steerable Catheter
Item #: 320100 (Marketed in Europe Only)
Code Information All lot numbers were the 4th digit contains the letter A through M. Ex. 07A''A''1234
Recalling Firm/
C. R.Bard, Inc./Electrophysiology Division
129 Concord Road
Billerica MA 01821
For Additional Information Contact Chris O. Fappiano
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 12 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.