APD Drain Manifold
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation has recalled 180 units of its APD Drain Manifold peritoneal dialysis product because certain product codes were distributed in the United States without FDA regulatory clearance. The affected product code is R5C4512 (UDI: 00085412008790), and the recall involves four specific lot numbers with expiration dates ranging from August 2022 to December 2023. The product was distributed nationwide across nine states: California, Missouri, Massachusetts, Arizona, Texas, Florida, New York, Maryland, and Ohio.
The recall source does not specify a remedy or recommended actions for affected consumers.
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: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.