Recall Z-1006-05 ยท DYG Catheter, Flow Directed
B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604057---------------T147 A427D1014KANI
| Date | Jul 16, 2005 (initiated May 25, 2005) |
| Status | Terminated |
| Reason | Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs. |
| Root cause | Other |
| Action | The firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005. |
| Quantity | 64 units |
| Distribution | Product was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan. |
| FDA record | Open on fda.gov |