Device 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.
Z-1703-2016
Product summary
- Event
- Event 74171
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)]
- Official record key
device-enforcement:Z-1703-2016
Official wording
Reason: Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
Code information: Catalog Number 471734, Lot Numbers: 0061482060 and 0061486821, expiration dates :1/31/2021 and 02/28/2021, respectively.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.