The FDA this week said the Fresenius Kabi recall of some Ivenix infusion systems is Class I, the most serious kind. Fresenius Kabi is recalling some Ivenix infusion systems due to a leak in the system that allows fluid to enter the administration set loading area near the air detector. The leak could damage the electrical system and result in … [Read more...] about Fresenius Kabi recall of Ivenix infusion systems in Class I
Recalls
Getinge’s Datascope has its second Class I recall in a month
The FDA issued a notice determining another recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate Class I recall earlier this month. The … [Read more...] about Getinge’s Datascope has its second Class I recall in a month
Getinge’s Datascope has another serious intra-aortic balloon pump recall
The FDA issued a notice determining a recall of Getinge subsidiary Datascope's Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company's Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in … [Read more...] about Getinge’s Datascope has another serious intra-aortic balloon pump recall
FDA sends warning letter to Olympus over endoscope manufacturing
The FDA issued Olympus a warning letter regarding adultered devices following an inspection of the company’s Tokyo facility. This marks the latest warning letter sent by the FDA to Olympus. The company received two separate letters at the end of last year. According to the letter, the agency conducted an inspection of the Tokyo facility … [Read more...] about FDA sends warning letter to Olympus over endoscope manufacturing
Getinge penalized in EU over life support system problems
The EU notified body DEKRA out of Germany has temporarily suspended the CE certificates for Getinge HLS and PLS sets, starting this month. The Swedish medtech company announced the suspension on Feb. 23. Health providers use the HLS and PLS for extracorporeal respiratory and/or cardiovascular support. Getinge had already announced potential … [Read more...] about Getinge penalized in EU over life support system problems
FDA labels Medtronic recall of some Mahurkar hemodialysis catheters as Class I
The FDA this week said the Medtronic (NYSE:MDT) recall of some Mahurkar hemodialysis catheters is Class I, the most serious kind. Medtronic is recalling its Mahurkar acute dual lumen high flow 13.5 Fr hemodialysis catheters, also known as Mahurkar QPlus, due to reports of a potential catheter hub defect that could cause leaks in a catheter's … [Read more...] about FDA labels Medtronic recall of some Mahurkar hemodialysis catheters as Class I
BD issues urgent field safety notice for Venovo venous stent system
BD has issued an urgent field safety notice for its Venovo venous stent system. The notice out of Germany warns of potential delayed deployment and silicone embolization if the proximal end of the Venovo venous stent system does not immediately expand upon deployment and remains connected to the stent cushion on the delivery system. According … [Read more...] about BD issues urgent field safety notice for Venovo venous stent system
FDA labels Medtronic recall of some endotracheal tubes as Class I
The FDA this week said the Medtronic recall of some NIM Contact Reinforced EMG endotracheal tubes is Class I, the most serious kind. Medtronic is recalling its NIM Contact Reinforced EMG endotracheal tubes and NIM Standard Reinforced EMG endotracheal tubes due to reports of obstruction of the endotracheal tube while in use in patients. Tube … [Read more...] about FDA labels Medtronic recall of some endotracheal tubes as Class I
LeMaitre Vascular warns on some Syntel Silicone over-the-wire embolectomy catheters
LeMaitre Vascular (NSDQ:LMAT) recently issued an urgent field safety notice for some of its Syntel Silicone over-the-wire embolectomy catheters. The Burlington, Massachusetts-based company issued the warning due to the French size next to the outside diameter symbol on the label not reflecting the 5 Fr catheter extrusion used on all models of … [Read more...] about LeMaitre Vascular warns on some Syntel Silicone over-the-wire embolectomy catheters
Gore voluntarily recalls some balloon catheters
W.L. Gore and Associates recently announced the voluntary product recall of its Molding and Occlusion Balloon (MOB) Catheters. The Newark, Delaware-based manufacturing company issued the warning due to complaints of leakage from the guidewire lumen and the y-hub during the preparation or use of the MOB catheters. The issue could result in … [Read more...] about Gore voluntarily recalls some balloon catheters
