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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJanuary 08, 2003
Date PostedFebruary 28, 2003
Recall Status1 Terminated 3 on May 03, 2012
Recall NumberZ-0603-03
Recall Event ID 25401
ProductBard 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
FEI Number 1000120754
Recalling Firm/
Manufacturer		 C. R.Bard, Inc./Electrophysiology Division
129 Concord Road
Billerica MA 01821
For Additional Information ContactChris 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
ActionBard Electrophysiology notified direct accounts by letter on 1.08.03 via Fed''X. Accounts are requested to return product.
Quantity in Commerce12 units
DistributionNationwide
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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