Category: Recalls

Recalls

Fresenius Kabi Recalls Ivenix Infusion Systems LVP Software

Fresenius Kabi is recalling their Ivenix Infusion System LVP software due to serious anomalies that could harm patients.

Recalls

GAO to Investigate FDA’s Medical Device Oversight

The Government Accountability Office (GAO) is launching an investigation into the U.S. FDA's potentially ineffective policies for recalling medical devices, prompted by concerns raised by Senators Durbin and Blumenthal regarding the slow response to recalls of Philips Respironics CPAPs, BiPAPs, and mechanical ventilators.

Recalls

B. Braun Medical Recalls Infusomat Infusion Pump Systems

B. Braun Medical, Inc. is recalling the Infusomat Space Volumetric Infusion Pump System due to faulty occlusion alarms that may lead to interruptions in the delivery of high-risk medications, potentially causing serious harm or death, with 51 complaints, one injury, and one death reported.

Recalls

Fresenius Kabi Recalls Ivenix Infusion Systems LVP Software

Fresenius Kabi is recalling their Ivenix Infusion System LVP software due to serious anomalies that could harm patients.

Abiomed Recalls Impella Left-Sided Blood Pumps

Jul 28, 2023

Abiomed issued the recall because the pumps’ instructions for use do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement.

Certain Draeger Medical Ventilators Get Class I Recall

Jul 14, 2023

Certain Draeger ventilators reportedly stopped ventilation because of a depleted battery, even after being re-connected to AC power.

Johnson & Johnson Megadyne Electrodes Nab Class 1 Recall

Jul 13, 2023

The FDA has labeled the recall of two types of Megadyne electrodes manufactured by Johnson & Johnson’s Ethicon as a class I, the most serious.

FDA: Philips Ventilator Recall Report Numbers Increasing

Jun 7, 2023

The FDA received an additional 6,000 medical device reports January 1, 2023-March 31, 2023, related to PE-PUR foam used in Philips ventilators and other devices recalled in June 2021.

Infusion System Replacement Batteries Get FDA Class I Recall

May 22, 2023

These infusion system replacement batteries were recalled because a defect has diminished how long they can be used to run the system, which may cause the system to shut down an ongoing infusion.

ECRI Announces Recipients of 2023 Alerts Impact Award

May 18, 2023

ECRI has announced the winners of its 2023 Alerts Impact Award, recognizing members of its Alerts Workflow solution for their outstanding implementation of recall management programs in healthcare organizations.

Recalls

RRD Simplifies Medical Device Recall Notification Process

RRD's solution aims to ensure end-to-end support throughout the complex recall notification process for medical device companies.