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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: May 27, 2022
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Affected Products

Product: 5 Prong Manifold Set (with Luer Connectors)

Product code: R5C4427; UDI: 00085412008691; Lot Number: H17D26065 (exp. date: 04/26/2022), Lot Number: H17I18046 (exp. date: 09/18/2022), Lot Number: H18C20051 (exp. date:03/20/2023), Lot Number: H19J24041 (exp. date:10/24/2024)

Lot Numbers:
R5C4427
Number
Number
Number
Number
Product: Effluent Sample Bag

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)

Lot Numbers:
R5C4476
Number
Number
Number
Number
Number
Number
Number
Number
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Product: 3,65 m Extension Set with Luer-lock Connector

Product code: R5C4480F; UDI: 00085412577142; Lot Number: H19G12025 (exp. date: 07/12/2024)

Lot Numbers:
R5C4480F
Number
Product: APD Drain Manifold

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)

Lot Numbers:
R5C4512
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Number
Number
Number
Product: 15 Liters Drain Bag

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)

Lot Numbers:
R5C4145P
Numbers
Product: Locking Cap for PD Catheter Adapter

Product code: R5C4169; UDI: 00085412008639; Lot Number: H20K02067 (exp. date: 10/31/2025)

Lot Numbers:
R5C4169
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90032
Status: Active
Manufacturer: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 6 products (510 units; 75 units; 180 units; 78 units; 60 units; 180 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.