Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. B
FDA device recall Z-1116-2007 · posted 2007-07-23 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Cracks at the Catheter Tip
- Action taken
- On 6/5/07, a Product Removal Notice was issued to the only distributor that received the product in Japan
- Root cause
- Other
- Status
- Terminated
- Product code
- DYG
- Quantity affected
- 4,695
- Distribution
- International ONLY- Japan
- Date initiated
- 2007-06-05
- Date posted
- 2007-07-23
- Date terminated
- 2007-10-31
- Location
- Allentown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVA BALLOON THERMODILUTION INFUSION (K832287) | Nova Medical Specialties | 1983-10-19 |