Baxter Healthcare Corporation: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

Is my product affected?

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

• UPC 00085412498683

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

What happened

Baxter Healthcare Corporation is updating the instructions for use (IFU) for the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) to provide safety communication regarding cleaning practices. Approximately 152,539 units with product code 35700BAX2 have been distributed throughout the United States, U.S. Virgin Islands, Puerto Rico, Canada, and various Caribbean nations including Barbados, Trinidad and Tobago, Jamaica, the Bahamas, Bermuda, and Guyana.

The record does not specify a remedy or actions consumers should take regarding this communication.

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

Hazard

Baxter is updating the device IFU for safety communication regarding cleaning practices.

Details from the source

Reason for recall: Baxter is updating the device IFU for safety communication regarding cleaning practices. Distribution: Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana) Quantity: 152,539 units Lot/code info: Product Code: 35700BAX2, All Serial Numbers; GTIN 00085412498683

Source

Official record: FDA (Device enforcement) ↗

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

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