FDA Recall
Terminated
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: Z-0593-03
·
Initiated November 21, 2002
Recall
- Recall Number
- Z-0593-03
- Event Number
- 25424
- Firm
- Jomed Catheters, Inc.
- FEI Number
- 1000120334
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 21, 2002
- Posted
- February 28, 2003
- Terminated
- February 28, 2003
- Address
- 604 Queensbury Avenue, Queensbury, NY, 12804
Description
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
6 Fr. catheters packaged and labeled as 5 Fr.
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.
Distribution
There was no U.S. distribution. The product was distributed to three consignees in Germany, Hungary and Italy.
Quantity
50 catheters