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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 30, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on January 19, 2006
Recall Number Z-0638-04
Recall Event ID 28388
510(K)Number K983819  
Product Classification Prosthesis, Vascular Graft, Of 6mm And Greater Diameter - Product Code DSY
Product HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch.

Product Catalog Numbers:
HEK06/75CPUT;
HEK08/75CPUT;
HEK14/75CPUT;
HEK08/120CPUT;
HEK10/75CPUT;
HEK25/100CPUT;
HEK12/75CPUT;
HEK10/150CPUT.
Code Information Lot Numbers: 03G03; 03H08; 03J25; 03G10; 03H28; 03K02; 03G17; 03J04; 03K09; 03G24; 03J11; 03K16; 03G31; 03J18; 03K23.
Recalling Firm/
Manufacturer		 Datascope Corporation
14 Philips Pkwy
Montvale NJ 07645-1811
For Additional Information Contact Mr. Vincent Cafiso
201-307-5476
Manufacturer Reason
for Recall		 Water permeability of the patch is out of specification.
FDA Determined
Cause 2		 Other
Action Recall letters were sent to the customers via US Mail return receipt on 12/30/2003.
Quantity in Commerce 710 units
Distribution The product has been shipped nationwide to 53 hospitals, 4 government hospitals, and 3 sales representatives.
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 = DSY and Original Applicant = INTERVASCULAR, INC.
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