5 Prong Manifold Set (with Luer Connectors)
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation recalled 180 units of its 5 Prong Manifold Set with Luer Connectors (product code R5C4427) because certain peritoneal dialysis product codes lack FDA regulatory clearance and were distributed in the United States in error. The affected units were distributed nationwide across California, Missouri, Massachusetts, Arizona, Texas, Florida, New York, Maryland, and Ohio, with lot numbers H17D26065, H17I18046, H18C20051, and H19J24041 expiring between April 2022 and October 2024.
The recall notice does not specify any remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Reason for recall: Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. Distribution: US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH. Quantity: 180 units Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.