Device product
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Z-1119-2021
Product summary
- Event
- Event 87150
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 385 devices
- Official record key
device-enforcement:Z-1119-2021
Official wording
Reason: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Code information: UDI 07332414007881, All lots within expiry
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.