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FDA (Device enforcement)Recalled 2022-02-25closedclass ii

Baxter Healthcare Corporation: MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

Is my product affected?

MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

  • UPC 0085412476261
  • UPC 0085412008776
  • UPC 0085412008783
  • UPC 0085412050768

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling 498 units of MiniCap Extended Life PD Transfer Sets across 16 U.S. states and the District of Columbia. The devices were distributed without the required regulatory clearance. The recalled products include four product codes (5C4482S, R5C4482, R5C4483, and R5C4484) with multiple lot numbers and expiration dates ranging from 2022 through 2026.

The affected devices were distributed nationwide in California, Colorado, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, and the District of Columbia. The source document does not specify a remedy or instructions for what consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Devices distributed lacked regulatory clearance.

Details from the source

Reason for recall: Devices distributed lacked regulatory clearance. Distribution: US Nationwide distribution in the states of California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, and Texas. Quantity: 498 units Lot/code info: Product Code 5C4482S, UDI: 0085412476261; Lot Number (Expiration Date): H20F02074 (06/02/2025) and H21C31053 (03/31/2026) Product Code R5C4482, UDI: 0085412008776; Lot Number (Expiration Date): H18E18050 (05/18/2023), H20K06084 (11/06/2025), H20L08070 (12/08/2025), H21E07058 (05/07/2026), H21F07049 (06/07/2026), H21F08070 (06/08/2026), H21F28060 (06/28/2026), H21K16066 (11/16/2026) Product Code R5C4483, UDI: 0085412008783; Lot Number (Expiration Date): H18A12037 (01/12/2023) and H20K06035 (11/06/2025) Product Code R5C4484, UDI: 0085412050768; Lot Number (Expiration Date): H17H03057 (08/03/2022), H18G16076 (07/16/2023), H19E31052 (05/31/2024), H21B16056 (02/16/2026)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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