Recall Z-1703-2016— B. Braun Medical, Inc.

Name: FDA recall Z-1703-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-26

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2016-04-26, terminated 2017-03-10. It names one FDA 510(k) clearance: K760388. Product: WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.. Reason: Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-26
Terminated: 2017-03-10
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K760388 — CATHETER, VEIN (VENOFIX)B. Braun Instruments·cleared 1976-11-02

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

WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.

Reason for recall

Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

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