WebCME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion Thursday, March 19, 2024. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. WebJun 16, 2024 · Class 1 Device Recall BodyGuard Microset, Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy. On 06/16/20, Urgent Medical Device Recall Correction and Removal notices …
Medical Device Recalls
WebMay 25, 2024 · CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion. 03/30/20. 158. 0. 0. Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture. 03/30/20. 50. 10. 1. CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to … WebSep 16, 2024 · BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously. Code Information: Catalog Number: A120-003XYVA UDI: 00818666020146 Lot Numbers: 10636 10653 12117 … how does a ftir work
BD I.V Sets and Accessories
WebCME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion The FDA has identified this as a Class I … WebMay 1, 2024 · The recall and market removal affects seven models of the BodyGuard infusion pumps and approximately 28,400 devices. Earlier in September 2024, the company recalled certain lots of BodyGuard Microset infusion sets, when used with the BodyGuard infusion pump, may under-deliver fluids up to 50% at the highest flow rates. WebThe Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). how does a fuel pump on a riding mower work