Device product
15 Liters Drain Bag
Z-1141-2022
Product summary
- Event
- Event 90032
- Status
- Terminated
- Classification
- Class II
- Quantity
- 510 units
- Official record key
device-enforcement:Z-1141-2022
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: R5C4145P; UDI: 05413760005386; Lot Numbers: H17H14104 (exp. date: 07/31/2022), H20K02117 (exp. date: 11/02/2025), H21H24081 (exp. date: 08/24/2026)
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.