Recall Z-1116-2007 ยท DYG Catheter, Flow Directed
B. Braun Medical, Inc.
Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.
| Date | Jul 23, 2007 (initiated Jun 5, 2007) |
| Status | Terminated |
| Reason | Cracks at the Catheter Tip |
| Root cause | Other |
| Action | On 6/5/07, a Product Removal Notice was issued to the only distributor that received the product in Japan |
| Quantity | 4,695 |
| Distribution | International ONLY- Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K832287 | NOVA BALLOON THERMODILUTION INFUSION Nova Medical Specialties, Oct 19, 1983 |