Z-0593-03

JOGRAPHY Cardiovascular Angiographic Catheter, 5F * pigtail * tapered with perfusion ports *** MEDI-DYNE...

Name: Z-0593-03 JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion ports *** MEDI-DYNE...
Creator: Jomed Catheters, Inc.
Published: 2002-11-21
License: https://open.fda.gov/license/

Jomed Catheters, Inc. / initiated 2002-11-21 / Terminated / root cause: labeling and UDI

FDA source

Jomed Catheters, Inc. began a recall of JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion ports *** MEDI-DYNE, INC., 604 Queensbury Ave., Queensbury, New York... on 2002-11-21. The reason FDA records is "6 Fr. catheters packaged and labeled as 5 Fr". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0593-03
Status: Terminated
Initiated: 2002-11-21
Posted: 2003-02-28
Terminated: 2003-02-28
Recalling firm: Jomed Catheters, Inc.
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.
Reason for recall: 6 Fr. catheters packaged and labeled as 5 Fr.
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: Lot Number 41340

K000825Class II4F-7F Medi-Dyne Torq Flow Xlb Angiographic CatheterMedi-Dyne, Inc. / cleared 2000-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)