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.
| Date | Feb 28, 2003 (initiated Nov 21, 2002) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000825 | 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER Medi-Dyne, Inc., Sep 21, 2000 |