15 Liters Drain Bag
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling 510 units of its 15-liter Peritoneal Dialysis Drain Bag because certain product codes were distributed in the United States without FDA regulatory clearance. The affected product code is R5C4145P (UDI: 05413760005386), and the recall involves three lot numbers: H17H14104 (expiration date 07/31/2022), H20K02117 (expiration date 11/02/2025), and H21H24081 (expiration date 08/24/2026). The products were distributed nationwide across California, Missouri, Massachusetts, Arizona, Texas, Florida, New York, Maryland, and Ohio.
The source does not specify a remedy or what affected consumers should do in response to this recall.
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: 510 units Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.