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.
FDA Recall Z-0593-03 · Posted 2003-02-28
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Recalling FirmJomed Catheters, Inc.
Recall StatusTerminated
Date Initiated2002-11-21
Date Terminated2003-02-28
Product Quantity50 catheters
Reason for Recall
6 Fr. catheters packaged and labeled as 5 Fr.
Firm 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.
Root Cause
Other
Distribution Pattern
There was no U.S. distribution. The product was distributed to three consignees in Germany, Hungary and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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