FDAClass IIJune 8, 2022

5 Prong Manifold Set recall

5 Prong Manifold Set (with Luer Connectors)

Why was 5 Prong Manifold Set recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product
5 Prong Manifold Set (with Luer Connectors)
Recalling firm
Baxter Healthcare Corporation
Quantity
180 units
Distribution
US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Recall date
June 8, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls