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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 patchsee related information
Date Initiated by FirmDecember 13, 2002
Date PostedFebruary 26, 2003
Recall Status1 Terminated 3 on May 27, 2003
Recall NumberZ-0577-03
Recall Event ID 25286
510(K)NumberK001785 
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
ProductSurgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
Code Information lots SB102671, SB102908, LB203536, SB10189, SB101148, SB101402, SB102006 and SB102670.
FEI Number 3002340648
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
ActionThe remaining stocks were picked up at the hospital consignees on December 13 and 17, 2002.
Quantity in Commerce153
DistributionIndiana
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DXY
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