Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista
FDA device recall Z-0933-03 · posted 2003-06-12 · Terminated
Recall details
- Recalling firm
- Braun,B Medical Inc
- Reason for recall
- possible leakage
- Action taken
- The recalling firm sent recall letters to their direct accounts dated 4/14/03. The recall letters inform the accounts of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 2577300 units
- Distribution
- The products were shipped to medical facilities and distributors nationwide. The products were also shipped to the firm''s German facility, Canada and Spain.
- Date initiated
- 2003-04-14
- Date posted
- 2003-06-12
- Date terminated
- 2004-01-29
- 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 |
|---|---|---|
| V2 INJECTION SITE (K955585) | B.Braun Medical, Inc. | 1996-05-15 |
| FILTERED EXTENSION SETS (K942988) | B. Braun of America, Inc. | 1995-07-14 |
| LOW VOLUME MULTIPORT (K943770) | B. Braun of America, Inc. | 1995-04-10 |
| IV ADMINISTRATION SET WITH BACKCHECK (K790062) | National Patent Development Corp. | 1979-04-10 |
| STOPCOCKS (K760383) | B. Braun Instruments | 1976-11-02 |