Device product
3,65 m Extension Set with Luer-lock Connector
Z-1145-2022
Product summary
- Event
- Event 90032
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-1145-2022
Official wording
Reason: Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Code information: Product code: R5C4480F; UDI: 00085412577142; Lot Number: H19G12025 (exp. date: 07/12/2024)
Distribution pattern: US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Derived failure modes
-
Unknown
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.