Recall Z-0030-2007 ยท NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Arrow International Inc
Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.
| Date | Oct 12, 2006 (initiated Jun 20, 2006) |
| Status | Terminated |
| Reason | The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed. |
| Root cause | Other |
| Action | Recall letter was sent to customers on 6/20/2006 by US mail. |
| Quantity | 11 units |
| Distribution | Medical facilities located in MD, IL, MO, MA and United Kingdom, for a total of 5. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.