Agency classClass IIOur severity:High FDA (Devices)·Z-1143-2022·Announced 2022-06-08

Baxter Peritoneal Dialysis Manifold Sets Recalled for Lack of FDA Clearance

Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets used in peritoneal dialysis. These products were distributed without FDA regulatory clearance to facilities across nine US states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II product without reported illnesses, injuries, or hospitalizations. The hazard is regulatory non-compliance (lack of FDA clearance), fitting the 'risk-of-harm products without reported injury' category per the rubric.

Plain-English summary

Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets with Luer Connectors (product code R5C4427, UDI: 00085412008691) used in peritoneal dialysis treatment. The affected units are from four lot numbers: H17D26065 (expires 04/26/2022), H17I18046 (expires 09/18/2022), H18C20051 (expires 03/20/2023), and H19J24041 (expires 10/24/2024).

The recalled products do not have FDA regulatory clearance and were distributed in the United States in error.

The products were distributed nationwide to healthcare facilities in California, Missouri, Massachusetts, Arizona, Texas, Florida, New York, Maryland, and Ohio.

Healthcare facilities that have received these manifold sets should stop use and contact Baxter Healthcare Corporation for return or replacement instructions.

The recalled product

Product: 5 Prong Manifold Set (with Luer Connectors)
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Peritoneal Dialysis
Hazard: lack-of-fda-clearance
uncertified-medical-device
Affected units: 180

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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)

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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