Recall Z-2022-2014 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
| Date | Jul 9, 2014 (initiated May 29, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942988 | FILTERED EXTENSION SETS B. Braun of America, Inc., Jul 14, 1995 |