| | Class 2 Device Recall Jography |  |
| Date Initiated by Firm | November 21, 2002 |
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| Date Posted | February 28, 2003 |
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| Recall Status1 |
Terminated 3 on February 28, 2003 |
| Recall Number | Z-0593-03 |
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| Recall Event ID |
25424 |
| 510(K)Number | K000825 |
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| 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. |
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| Code Information |
Lot Number 41340 |
| FEI Number |
1000120334
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Recalling Firm/
Manufacturer |
Jomed Catheters, Inc.
604 Queensbury Avenue
Queensbury NY 12804
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Manufacturer Reason
for Recall | 6 Fr. catheters packaged and labeled as 5 Fr. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | 50 catheters |
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| Distribution | There was no U.S. distribution. The product was distributed to three consignees in Germany, Hungary and Italy.
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code =
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