FDA (Devices) recall action 86062
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Baxter is updating the device IFU for safety communication regarding cleaning practices.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Baxter Healthcare is recalling 152,539 SIGMA Spectrum Infusion Pumps to update the Instructions for Use (IFU) regarding cleaning practices.
Baxter Healthcare is recalling 146,224 Spectrum IQ Infusion Systems to update instructions for use regarding cleaning practices.
Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps to update the Instructions for Use (IFU) regarding cleaning practices.
Baxter is updating the Instructions for Use for the SIGMA Spectrum Infusion Pump to clarify safety communication regarding cleaning practices.