FDA-Device2016-06-01Class II

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.

B. Braun Medical, Inc.
Hazard

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

Sold states
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.
Affected count
5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)]
Manufactured in
901 Marcon Blvd, N/A, Allentown, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1703-2016

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