9 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.
FDA Recall
Terminated
·Mallinckrodt Inc·Product code IZQ·May 20, 2011
Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH The Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures.
FDA Recall
Terminated
·Mallinckrodt Inc·Product code IZQ·October 11, 2011
The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system.
FDA Recall
Terminated
·Mallinckrodt Inc·Product code IZQ·April 7, 2008
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
FDA Enforcement
Class II
·Terminated·Data Innovations, LLC·October 31, 2018
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
FDA Recall
Terminated
·Data Innovations, LLC·Product code JQP·August 29, 2018
ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study
FDA Recall
Terminated
·Salter Laboratories, Division of Regulatory Affairs·Product code BZQ·December 21, 2010
Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.
FDA Recall
Terminated
·Respironics, Inc.·Product code BZQ·June 4, 2004
ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch
FDA Recall
Terminated
·Convatec Inc.·Product code EZQ·September 17, 2010
Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code BZQ·May 24, 2004