Device product
Effluent Sample Bag
Z-1144-2022
Product summary
- Event
- Event 90032
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78 units
- Official record key
device-enforcement:Z-1144-2022
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: R5C4476; UDI: 00085412008738; Lot Number: H18E25030 (exp. date: 04/30/2023), Lot Number: H19D12097(exp. date: 03/31/2024), Lot Number: H19K14040 (exp. date: 10/31/2024),Lot Number: H20B19101 (exp. date: 01/31/2025),Lot Number: H20F17064 (exp. date: 05/31/2025),Lot Number: H20I28073 (exp. date: 08/31/2025),Lot Number: H21D01054 (exp. date: 03/31/2026),Lot Number: H21I24030 (exp. date: 08/31/2026), Lot Number: H21J13040 (exp. date:09/30/2026)
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.