Search results
Results From The WOW.Com Content Network
The medical device maker started the recall process on Dec. 27 last year and has recalled 66,390 devices in the United States. The recalled devices were distributed for two years until Oct. 10, 2023.
There have been 51 complaints, one death related to this recall and one reported injury, the FDA said. The company has asked customers to not use the device for high-risk medications, and only use ...
The devices are used in patients undergoing cardiac and non-cardiac surgery, and to treat those who have had heart failure or have acute coronary syndrome, a group of diseases in which blood flow ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
The warning to healthcare providers followed the company's recall over incompatibility concerns with syringe pumps. (Reporting by Pratik Jain in Bengaluru; Editing by Shilpi Majumdar and Sriraj ...
The U.S. Food and Drug Administration issued a Class I recall, the agency's most serious, for the Medfusion syringe pump, the third major FDA recall for the line of devices made in Oakdale. Smiths ...
The recall applies to Life2000 ventilators with the product code MS01-0118 that have the attached battery charger dongle, and were distributed in the U.S. from Aug. 21, 2023 to April 2, 2024 ...
The FDA has issued a statement following the Class I recall for an IOS app used in conjunction with insulin pumps after 224 injuries were reported.