Right Heart Catheter Product Line: Catalog Number 604028------------T047(90) 427D1022I.
FDA device recall Z-1004-05 · posted 2005-07-16 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Action taken
- The firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYG
- Quantity affected
- 398 units
- Distribution
- Product was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan.
- Date initiated
- 2005-05-25
- Date posted
- 2005-07-16
- Date terminated
- 2006-12-14
- 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 CATH. (K841639) | Nova Medical Specialties | 1984-08-12 |
| NOVA BALLOON THERMODILUTION INFUSION (K832287) | Nova Medical Specialties | 1983-10-19 |
| BALLOON WEDGE PRESSURE, ANGIOGRAPHIC (K822806) | Nova Medical Specialties | 1982-11-01 |