Device product
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.
Z-1776-2018
Product summary
- Event
- Event 79750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6044
- Official record key
device-enforcement:Z-1776-2018
Official wording
Reason: The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Code information: Lots B151130E2 and B161115E0
Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.
Derived failure modes
-
Unknown
The sterility of the device cannot be assured. There is a potential for an increased risk of infection.