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U.S. Department of Health and Human Services

Class 2 Device Recall Surgisis peripheral vascular patch

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  Class 2 Device Recall Surgisis peripheral vascular patch see related information
Date Initiated by Firm December 13, 2002
Date Posted February 26, 2003
Recall Status1 Terminated 3 on May 27, 2003
Recall Number Z-0577-03
Recall Event ID 25286
510(K)Number K001785  
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
Product Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
Code Information lots SB102671, SB102908, LB203536, SB10189, SB101148, SB101402, SB102006 and SB102670.
Recalling Firm/
Manufacturer		 Cook Biotech, Inc.
3055 Kent Avenue
West Lafayette IN 47906
For Additional Information Contact
888-299-4224
Manufacturer Reason
for Recall		 Adverse events- suspected pseudoaneurysm
FDA Determined
Cause 2		 Other
Action The remaining stocks were picked up at the hospital consignees on December 13 and 17, 2002.
Quantity in Commerce 153
Distribution Indiana
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 = DXY and Original Applicant = COOK BIOTECH, INC.
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