STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
FDA device recall Z-2022-2014 · posted 2014-07-09 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.
- Action taken
- An urgent medical device correction notification, dated June 3, 2014, describing the product, problem, and actions to be taken, was sent to end users and distributors.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 10,835
- Distribution
- USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.
- Date initiated
- 2014-05-29
- Date posted
- 2014-07-09
- Date terminated
- 2014-12-10
- 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 |
|---|---|---|
| FILTERED EXTENSION SETS (K942988) | B. Braun of America, Inc. | 1995-07-14 |