Device product
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).
Z-2088-2021
Product summary
- Event
- Event 87998
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 cases
- Official record key
device-enforcement:Z-2088-2021
Official wording
Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions
Code information: Lot Number: 20LR08111 UDI: (01)00840861100811
Distribution pattern: US Distribution to: TX only
Derived failure modes
-
Unknown
Exposed to freezing temperatures due to refrigerated truck malfunctions