Recall Z-0933-03 ยท FPA Set, Administration, Intravascular
Braun,B Medical Inc
Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Sets; Extension Sets; Anesthesia Sets; Rate Flow Extension Sets; and Rate Flow IV Administration Sets.
| Date | Jun 12, 2003 (initiated Apr 14, 2003) |
| Status | Terminated |
| Reason | possible leakage |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K760383 | STOPCOCKS B. Braun Instruments, Nov 2, 1976 |
| K790062 | IV ADMINISTRATION SET WITH BACKCHECK National Patent Development Corp., Apr 10, 1979 |
| K942988 | FILTERED EXTENSION SETS B. Braun of America, Inc., Jul 14, 1995 |
| K943770 | LOW VOLUME MULTIPORT B. Braun of America, Inc., Apr 10, 1995 |
| K955585 | V2 INJECTION SITE B.Braun Medical, Inc., May 15, 1996 |