AngioDynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507602
FDA device recall Z-0965-03 · posted 2003-07-02 · Terminated
Recall details
- Recalling firm
- MedAmicus,Inc
- Reason for recall
- Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Action taken
- The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 281 boxes
- Distribution
- The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. Th
- Date initiated
- 2003-06-06
- Date posted
- 2003-07-02
- Date terminated
- 2004-07-02
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MADETT (K021044) | Wolfe Tory Medical, Inc. | 2002-09-11 |