Recall Z-0968-03 ยท DYB Introducer, Catheter
MedAmicus,Inc
Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011
| Date | Jul 2, 2003 (initiated Jun 6, 2003) |
| Status | Terminated |
| Reason | Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. |
| Root cause | Other |
| Action | The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products. |
| 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. There was no direct distribution to foreign or U.S Government accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021044 | MADETT Wolfe Tory Medical, Inc., Sep 11, 2002 |