Recall Z-1024-04 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Medtronic Vascular
Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
| Date | Jul 20, 2004 (initiated Jun 8, 2004) |
| Status | Terminated |
| Reason | medical device for which sterility may be compromised because of improper seal. |
| Root cause | Other |
| Action | A notice letter was sent to all 40 consignees, and phone contact is made. A physical visit to the account would be conducted to collect affected product. |
| Quantity | 193 units |
| Distribution | Product was distributed to 40 hospitals |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.