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U.S. Department of Health and Human Services

Class 2 Device Recall Jography

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  Class 2 Device Recall Jography see related information
Date Initiated by Firm November 21, 2002
Date Posted February 28, 2003
Recall Status1 Terminated 3 on February 28, 2003
Recall Number Z-0593-03
Recall Event ID 25424
510(K)Number K000825  
Product JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion ports *** MEDI-DYNE, INC., 604 Queensbury Ave., Queensbury, New York 12804 *** Single use, sterile, disposable intravascular catheters with an atraumatic tip.
Code Information Lot Number 41340
Recalling Firm/
Manufacturer		 Jomed Catheters, Inc.
604 Queensbury Avenue
Queensbury NY 12804
Manufacturer Reason
for Recall		 6 Fr. catheters packaged and labeled as 5 Fr.
FDA Determined
Cause 2		 Other
Action Consignees notified via e-mail on 11/21/2002. The consignees were instructed to contact their customers and return product to Jomed''sdistribution center in the Netherlands.
Quantity in Commerce 50 catheters
Distribution There was no U.S. distribution. The product was distributed to three consignees in Germany, Hungary and Italy.
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 = and Original Applicant = MEDI-DYNE, INC.
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