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/ 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 |
12 units |
Distribution |
Nationwide |
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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.
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