JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion ports *** MEDI-DYNE, INC., 604
FDA device recall Z-0593-03 · posted 2003-02-28 · Terminated
Recall details
- Recalling firm
- Jomed Catheters, Inc.
- Reason for recall
- 6 Fr. catheters packaged and labeled as 5 Fr.
- Action taken
- 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
- Status
- Terminated
- Quantity affected
- 50 catheters
- Distribution
- There was no U.S. distribution. The product was distributed to three consignees in Germany, Hungary and Italy.
- Date initiated
- 2002-11-21
- Date posted
- 2003-02-28
- Date terminated
- 2003-02-28
- Location
- Queensbury, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER (K000825) | Medi-Dyne, Inc. | 2000-09-21 |