PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 1, 2016 Initiated: April 26, 2016 #Z-1703-2016

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.

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)]
Distribution
Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by B. Braun Medical, Inc.. Units affected: 5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)].
Why was this product recalled?
Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 1, 2016. Severity: Moderate. Recall number: Z-1703-2016.