Summary Company Announcement Date: November 13, 2023 FDA Publish Date: November 17, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Acetaminophen Instability Company Name: KinderFarms, LLC Brand Name: Brand Name(s) Product Description: Product Description OTC Pain and Fever Reliever for Infants and Kids Company Announcement FOR IMMEDIATE RELEASE – November 13,…
B. Braun Medical, Inc. Recalls Infusomat® Space® Large Volume Pump, Wireless and Infusomat® Space® Large Volume Pump, Non-Wireless BATTERY PACK Due to Faulty Occlusion Alarm
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. Please be aware, this recall is a correction, not a product removal. Recalled Product Device Use The Infusomat® Space Volumetric Infusion Pump System, which includes the Infusomat Space…
Asensus Surgical Inc. Recalls Senhance Surgical System Due to Malfunctions with Unintended Movement of the Robotically-Assisted Surgical Device
Please be aware, this recall is a correction, not a product removal. 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 (Include the following information) Product Names: Asensus Senhance Surgical System Product Codes: See Recall Database…
Fresenius Medical Care Recalls Sanxin Single Use Syringes for Leakages
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 Product Names: Sanxin Single Use Sterile Syringes Product Codes and Part Numbers: Distribution Dates: April 30, 2021 to August 7, 2023 Devices Recalled in the U.S.: 12,477,300…
Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing
Please be aware, this recall is a correction, not a product removal. 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 Product Names: Novum IQ Syringe Pump Product Codes: All Serial Numbers – See Recall Database Entry…
Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe Pumps
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. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: Cardinal Health Monoject single use Luer lock syringes 1, 6, 12, 20,…
Covidien LLC Recalls McGRATH MAC Video Laryngoscope Due to Stolen Defective Products
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 (Include the following information) Product Names: McGRATH™ MAC Video Laryngoscopes Product Codes: See Recall Database Entry Item Code: 301-000-000 Distribution Dates: July 5, 2019 to July 14,…
Labeling Updates for BD Mesh Products – Letter to Health Care Providers
November 9, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about labeling updates for Becton, Dickinson and Company (BD) mesh products: Phasix Mesh Phasix ST Mesh Phasix Plug and Patch Phasix ST Mesh with Open Positioning System (OPS) Phasix ST Mesh with Echo 2 Positioning System, and GalaFLEX Lite Scaffold…
Do Not Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile: FDA Safety Communication
Date Issued: November 6, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands. On November 6, 2023, Nurse Assist, LLC announced a recall…
Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada
Summary Company Announcement Date: November 06, 2023 FDA Publish Date: November 06, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Lack of sterility assurance Company Name: Nurse Assist, LLC Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Company…