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Baxter Issues Urgent Medical Device Recall for Volara System Single-Patient Use Circuit.

Source :
Medical Letter on the CDC & FDA; 2024, p438-438, 1p
Publication Year :
2024

Abstract

Baxter International Inc. has issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly. The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. While no injuries have been reported, if the plug disconnects during therapy, it may lead to an interruption or delay of care. Baxter is working with customers to replace the affected products. The recall applies to specific product codes and was distributed in the United States between August 26, 2022, and December 30, 2023. Customers are advised to visually inspect the nebulizer port prior to therapy and report any adverse events to Baxter or the FDA. [Extracted from the article]

Details

Language :
English
ISSN :
15324648
Database :
Supplemental Index
Journal :
Medical Letter on the CDC & FDA
Publication Type :
Periodical
Accession number :
178630861