CDRH New - May 23, 2023

U.S. Food and Drug Administration sent this bulletin at 05/23/2023 08:30 AM EDT

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May 23, 2023

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 22, 2023. To view listings for other dates, see CDRH New - News and Updates.

Consumer Information: ADVIA Centaur HBc Total 2 (HBcT2), ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC), Atellica IM HBc Total 2 (HBcT2), Atellica IM HBc Total Quality Control (HBcT2 QC) - P210019/S002 (Siemens Healthcare Diagnostics Inc.)
Class I Recall: ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery

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