Class 2 Device Recall Jography

• Date Initiated by Firm: November 21, 2002
• Date Posted: February 28, 2003
• Recall Status: Terminated 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: 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 =