—#128169

Product

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K942988
Affected lot / code info: Product codes: 473547 and 473549 lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and 61367665, 3/31/2019.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.

Timeline

Recall initiated: 2014-05-29
Posted by FDA: 2014-07-09
Terminated: 2014-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128169. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.