WebMar 3, 2024 · Dive Brief: The number of Class I medical device recalls by the U.S. Food and Drug Administration hit a 15-year high in 2024, according to a report by Sedgwick. In 2024, the FDA oversaw 70 Class I recalls, its highest risk classification, compared to an average of 47 over the previous five years. Eighteen of the Class I recalls happened in … WebJan 26, 2024 · 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORPORATION - -
Baxter Issues Urgent Medical Device Correction to Reinforce …
Web5 rows · Jul 26, 2024 · Medical device giant Baxter International is recalling medication administrating software ... WebDec 2, 2024 · Recall of Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software by Baxter Healthcare due to unplanned shutdown. More on the FDA website. def of edging
Baxter
Baxter Healthcare Corporation is recalling the Abacus software application due to a risk that final printed bag labels for compounded mixtures may contain incorrect information. The issue may occur if a user unintentionally or incorrectly modifies a label template that is used to provide clinical care. Incorrect values … See more Abacus is a software application that performs calculations for compounding liquid doses of medications. When connected to a compounder that mixes these doses according to the calculation, the Abacus software … See more On June 22, 2024, Baxter Healthcare Corporation issued an Urgent Medical Device Correction letter to customers informing them that the company will perform a software … See more WebMar 10, 2024 · Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Life2000 Ventilation System due to the potential for patient oxygen desaturation (low blood ... WebFacilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday... feminine advocacy group