Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation has recalled approximately 241,304 units of Baxter Spectrum IQ Infusion Pumps (product code 3570009) worldwide. The pumps have the potential to deliver reduced amounts of medication or fail to deliver medication altogether, and in some cases may not alert users through an alarm when this occurs. This problem may result from incorrect administration set setup or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
The recalled pumps were distributed nationwide in the United States, Puerto Rico, and St. Thomas, as well as to government and military facilities and to customers in Canada, the Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago. All serial numbers with GTIN 00085412610900 are affected. The source document does not specify a remedy or what consumers should do if they have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
Reason for recall: There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps. Distribution: Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago. Quantity: 241,304 units Lot/code info: All serial numbers, GTIN 00085412610900.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.