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 00085412091570

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

What happened

Baxter Healthcare Corporation is updating safety instructions for the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) to provide new guidance on cleaning practices. Approximately 310,969 units with product code 35700BAX and all serial numbers have been distributed throughout the United States, U.S. Virgin Islands, Puerto Rico, Canada, and various Caribbean locations including Barbados, Trinidad and Tobago, Jamaica, the Bahamas, Bermuda, and Guyana.

The source document does not specify a remedy or any actions that affected consumers should take regarding this safety communication update.

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: 310,969 units Lot/code info: Product Code: 35700BAX, All Serial Numbers; GTIN 00085412091570

Source

Official record: FDA (Device enforcement) ↗

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

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