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MedWatch Safety Alert

Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication - FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems

FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed/treated.

Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve

The Babi.Plus Pressure Relief Manifold is used as part of a breathing circuit to assist infant patients to breathe. This device is being recalled due to a dislodged valve resulting in loss of pressure in the system. Teleflex issued a Medical Device Recall Notice to affected customers.

King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2

King Systems initiated a voluntary recall of One-Hundred Seventy-One (171) units of its King Vision Video Laryngoscope Adapter Size 1/2. The affected products have been found to exhibit a reversed image, which could potentially result in difficulty navigating during intubation and/or delay in intub

2020 Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication

FDA is informing health care providers and facility staff about cybersecurity vulnerabilities that may introduce risks to patients while being monitored using certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.

The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

FDA is sharing recommendations and updates to help improve duodenoscope reprocessing.

Surgical Gowns and Packs by Cardinal Health: FDA Statement - Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs

The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines.

Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer

FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).