SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device used to administer fluids from a
FDA device recall Z-0987-2014 · posted 2014-02-18 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- 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.
- Action taken
- A recall notification letter, dated January 7, 2014, was sent to Users and distributors.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 2,357,944
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-01-08
- Date posted
- 2014-02-18
- Date terminated
- 2014-11-03
- 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 |
|---|---|---|
| CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK (K060231) | Elcam Medical Acal | 2006-04-13 |
| V2 INJECTION SITE (K955585) | B.Braun Medical, Inc. | 1996-05-15 |
| LOW PROFILE SAFSITE Y-SITE (K954123) | B.Braun Medical, Inc. | 1995-11-21 |
| FILTERED EXTENSION SETS (K942988) | B. Braun of America, Inc. | 1995-07-14 |
| STOPCOCKS (K760383) | B. Braun Instruments | 1976-11-02 |