Effluent Sample Bag
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation recalled 78 units of Effluent Sample Bag (product code R5C4476) that were distributed across nine states including California, Missouri, Massachusetts, Arizona, Texas, Florida, New York, Maryland, and Ohio. These Peritoneal Dialysis products were distributed in the United States in error because they do not have FDA regulatory clearance.
The affected product involves nine lot numbers with expiration dates ranging from April 2023 through September 2026. The specific lot numbers are H18E25030, H19D12097, H19K14040, H20B19101, H20F17064, H20I28073, H21D01054, H21I24030, and H21J13040. The source document does not specify what action consumers should take 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: 78 units Lot/code info: Product code: R5C4476; UDI: 00085412008738; Lot Number: H18E25030 (exp. date: 04/30/2023), Lot Number: H19D12097(exp. date: 03/31/2024), Lot Number: H19K14040 (exp. date: 10/31/2024),Lot Number: H20B19101 (exp. date: 01/31/2025),Lot Number: H20F17064 (exp. date: 05/31/2025),Lot Number: H20I28073 (exp. date: 08/31/2025),Lot Number: H21D01054 (exp. date: 03/31/2026),Lot Number: H21I24030 (exp. date: 08/31/2026), Lot Number: H21J13040 (exp. date:09/30/2026)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.