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U.S. Department of Health and Human Services

Class 2 Device Recall Bard SSV Split Sheath with Valve Introducer System

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  Class 2 Device Recall Bard SSV Split Sheath with Valve Introducer System see related information
Date Initiated by Firm October 01, 2008
Date Posted November 07, 2008
Recall Status1 Terminated 3 on March 09, 2010
Recall Number Z-0280-2009
Recall Event ID 49575
510(K)Number K934901  
Product Classification Catheter introducer - Product Code DYB
Product 7F Bard SSV 13 cm Split Sheath with Valve and sideport
Catalog Number: 808700
Distributed By: Bard Electrophysiology. The product is Intended for introduction of various type of pacing leads and catheters
Code Information Lot Numbers: S25589 and S26178
Recalling Firm/
Manufacturer		 C. R.Bard, Inc./BardElectrophysiology Division
55 Technology Dr
Lowell MA 01851-5203
For Additional Information Contact SAME
908-277-8000
Manufacturer Reason
for Recall		 Failure to insert the guidewire through the introducer needle.
FDA Determined
Cause 2		 Process control
Action Bard issued a recall notice on 1 October 2008 [note that the letter is dated 29 September 2008] to all recipients of affected product via certified mail. Users are requested to discontinue use and return inventory. Contact Bard Customer Service at 1-800-824-8724 for assistance.
Quantity in Commerce 3,105 kits
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = THOMAS MEDICAL PRODUCTS, INC.
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