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FDA Medical Device Recalls (openFDA)

Jomed Catheters, Inc.: 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.

Recall number
Z-0593-03
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.
Status
Terminated
Initiated
2002-11-21
Posted
2003-02-28
Terminated
2003-02-28
Reason
6 Fr. catheters packaged and labeled as 5 Fr.
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
50 catheters
Distribution
There was no U.S. distribution. The product was distributed to three consignees in Germany, Hungary and Italy.
Lot, serial or model codes
Lot Number 41340
510(k) numbers
["K000825"]
PMA numbers
not on file
Product code
not on file
Firm FEI
1000120334
Firm city
Queensbury
Firm state
NY
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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