Baxter Healthcare Corporation: Spectrum IQ Infusion System with Dose IQ Safety Software

Is my product affected?

Spectrum IQ Infusion System with Dose IQ Safety Software

• UPC 00085412610900

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

What happened

Baxter Healthcare Corporation is updating the instruction for use (IFU) documentation for its Spectrum IQ Infusion System with Dose IQ Safety Software to provide new safety communication regarding cleaning practices. Approximately 146,224 units with Product Code 3570009 and all serial numbers have been distributed throughout the United States, U.S. Virgin Islands, Puerto Rico, Canada, and the Caribbean region including Barbados, Trinidad and Tobago, Jamaica, the Bahamas, Bermuda, and Guyana.

The recall record does not specify a remedy or action that affected consumers should take.

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: 146,224 units Lot/code info: Product Code: 3570009, All Serial Numbers; GTIN 00085412610900

Source

Official record: FDA (Device enforcement) ↗

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

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