Baxter Healthcare Corporation: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

Is my product affected?

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

• UPC 00085412091570

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 6) to provide safety communication regarding cleaning practices. The device has been distributed throughout the United States, St. Thomas USVI, Puerto Rico, and internationally including Canada and several Caribbean nations. A total of 9,352 units with product code 35700ABB and all serial numbers are affected.

The source does not specify a remedy or what action affected consumers should take regarding this 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: 9352 units Lot/code info: Product Code: 35700ABB, 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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