Device product
APD Drain Manifold
Z-1146-2022
Product summary
- Event
- Event 90032
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 units
- Official record key
device-enforcement:Z-1146-2022
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: R5C4512; UDI: 00085412008790; Lot Number: H18D03030 (exp. date: 04/03/2023), Lot Number: H18E31046 (exp. date: 05/31/2023), Lot Number: H18L04065 (exp. date:12/04/2023), Lot Number: H20H10073 (exp. date: 08/10/2022)
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.