Recall Z-2022-2014— B. Braun Medical, Inc.

Name: FDA recall Z-2022-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-29

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2014-05-29, terminated 2014-12-10. It names one FDA 510(k) clearance: K942988. Product: STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches. 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..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-29
Terminated: 2014-12-10
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K942988 — FILTERED EXTENSION SETSB. Braun of America, Inc.·cleared 1995-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.