Recall Z-0987-2014 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
| Date | Feb 18, 2014 (initiated Jan 8, 2014) |
| Status | Terminated |
| Reason | Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle free access on IV and Extension Sets. |
| Root cause | Process control |
| Action | A recall notification letter, dated January 7, 2014, was sent to Users and distributors. |
| Quantity | 2,357,944 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK Elcam Medical Acal, Apr 13, 2006 |
| K760383 | STOPCOCKS B. Braun Instruments, Nov 2, 1976 |
| K942988 | FILTERED EXTENSION SETS B. Braun of America, Inc., Jul 14, 1995 |
| K954123 | LOW PROFILE SAFSITE Y-SITE B.Braun Medical, Inc., Nov 21, 1995 |
| K955585 | V2 INJECTION SITE B.Braun Medical, Inc., May 15, 1996 |