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 King Vision Video Laryngoscope Reusable Adapter Size ½, (KVLVA12) Lot Numbers: 010614, 010629, 010657, 010668, 010670, 010722 Serial numbers: LHXXXXXXX10240, LHXXXXXXX10243, LHXXXXXXX10284, LHXXXXXXX10554, LHXXXXXXX10559, LHXXXXXXX10562, LHXXXXXXX10569, LHXXXXXXX10570,…
Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication
Date Issued: February 27, 2020 The U.S. Food and Drug Administration (FDA) wants to make consumers and health care providers aware that, to date, the FDA has not authorized for market any products using ozone gas or ultraviolet (UV) light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories (for example: hoses,…
UPDATE: Reduce the Risk of Cardiac Surgery Infection While Using the LivaNova Heater-Cooler System 3T: FDA Safety Communication
Date Issued: February 25, 2020 The U.S. Food and Drug Administration (FDA) is reminding health care providers and staff of ways to reduce the risk of cardiac surgery infection when using the LivaNova Heater-Cooler System 3T. This is an update to our safety communication issued in October 2018. As noted in the October 2018 safety…
Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles
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 Name and Version: PneumoDart, TM-317 Product Code: NSN 6515-01-655-9514 Lot Number:190524J69 Manufacturing Dates: June 03, 2019 to September 17, 2019 Distribution Dates: June 03, 2019 to September…
ResMed Recalls Stellar 100 and 150 Non-invasive and Invasive Ventilators Due to Sound Alarm Failure
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 Stellar Non-invasive and Invasive Ventilators Model Numbers: 100 and 150 with serial number range: 20160123307 to 22171057208 Manufacturing Dates: April 2016 to June 2017 Distribution Dates: April…
Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters
Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 20, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Catheter balloon may not deflate as intended Company Name: Abbott Brand Name: Brand Name(s) Product Description: Product Description Coronary dilatation catheters Company Announcement Abbott has voluntarily recalled specific lots of two catheters…
Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing
Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 21, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Possible underdosing or overdosing Company Name: Taro Pharmaceuticals U.S.A., Inc. Brand Name: Brand Name(s) Taro Pharmaceuticals U.S.A., Inc. Product Description: Product Description Phenytoin Oral Suspension USP, 125 mg/5 mL Company Announcement Taro Pharmaceuticals…
Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate
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: NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation CathetersModels: Balloon diameters 4.0mm, 4.5mm and 5.0mmLots: See a full list of affected devices Distribution…
Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway
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 Name and Version: COMFORT FLO Humidification System, REF 2410, Humidifier Nebulizer Kit Product Code: GTIN 14026704659347 Name and Version: COMFORT FLO Humidification System with Remote Temperature Port,…
Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication – FDA Requests Withdrawal of Weight-Loss Drug
[Posted 02/13/2020] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: FDA has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug. When FDA approved lorcaserin…