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Recall Observatory FDA recall evidence

Device product

Effluent Sample Bag

Z-1144-2022

April 21, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
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

    reason.no_named_rule · v1.0.0

    Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.