Summary Company Announcement Date: August 04, 2021 FDA Publish Date: August 04, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product is contaminated with bacteria (Burkholderia cepacia complex) Company Name: Eco-Med Pharmaceutical Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Ultrasound Gel Company Announcement Etobicoke, Ontario (August 4, 2021)…
Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen
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. Recalled Product V60 Plus ventilators and all V60 ventilators upgraded to enable High Flow Therapy (software version 3.00 and 3.10) Distribution Dates: May 1, 2009 to June 2, 2021…
BD to Begin Remediation for BD Alaris™ System Software
Summary Company Announcement Date: July 29, 2021 FDA Publish Date: August 02, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Infusion pump may not operate as expected Company Name: Becton, Dickinson and Company Brand Name: Brand Name(s) Product Description: Product Description Alaris System Company Announcement FRANKLIN LAKES, N.J., July 29, 2021 /PRNewswire/…
Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions
Philips Respironics has voluntarily recalled certain ventilators, BiPAP, and CPAP machines due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain…
Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals
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. The recall described in this notice is the same one that was announced in the FDA Safety Communication on June 30, 2021. Recalled Product Continuous Ventilator, Minimum Ventilatory Support,…
Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam
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. Recalled Product Mechanical ventilation devices: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent 200, BiPAP V30, BiPAP A30/Hybrid/A40 Serial Numbers: Devices manufactured before April 26, 2021, all serial numbers…
Vero Biotech Recalls GENOSYL DS; Nitric Oxide Delivery System Due to Software Error
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. Recalled Product GENOSYL DS; Nitric Oxide Delivery System Model Number: 601588-01 Serial Numbers: All Devices Manufacturing Dates: March 15, 2021 to April 5, 2021 Distribution Dates: March 15, 2021…
Statins: Drug Safety Communication – FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy
[Posted 07/20/2021] AUDIENCE: Patient, Health Professional, OBGYN, Cardiology, Endocrinology, Pharmacy ISSUE: The FDA is requesting revisions to the information about use in pregnancy in the prescribing information of the entire class of statin medicines. These changes include removing the contraindication against using these medicines in all pregnant patients. A contraindication is FDA’s strongest warning and is only…
Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Summary Company Announcement Date: July 16, 2021 FDA Publish Date: July 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitroso Varenicline content above ADI level Company Name: Pfizer Brand Name: Brand Name(s) Product Description: Product Description Smoking cessation treatment Company Announcement Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two…
Potential Concerns with NuVasive MAGEC System Implants – FDA Safety Communication
Date Issued: July 15, 2021 The U.S. Food and Drug Administration (FDA) is informing patients, their caregivers, and health care providers of potential mechanical failures and concerns about tissue incompatibility (biocompatibility) associated with components of the following NuVasive Specialized Orthopedics’ MAGEC devices: MAGEC Spinal Bracing and Distraction System MAGEC 2 Spinal Bracing and Distraction System MAGEC…