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
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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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