Device product
Locking Cap for PD Catheter Adapter
Z-1142-2022
Product summary
- Event
- Event 90032
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 units
- Official record key
device-enforcement:Z-1142-2022
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: R5C4169; UDI: 00085412008639; Lot Number: H20K02067 (exp. date: 10/31/2025)
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.