Summary Company Announcement Date: March 11, 2021 FDA Publish Date: March 11, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of sterility assurance Company Name: Sagent Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Phenylephrine Hydrochloride Injection Company Announcement Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of three…
Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength
Summary Company Announcement Date: March 09, 2021 FDA Publish Date: March 09, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect strength displayed on the label Company Name: Bryant Ranch Prepack Brand Name: Brand Name(s) BRP Pharmaceuticals Product Description: Product Description Spironolactone TB 25MG and 50MG Company Announcement Bryant Ranch Prepack is voluntarily…
Improper Use of Thermal Imaging Devices: FDA Safety Communication
Date Issued: March 4, 2021 The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature that improper use of these systems may provide inaccurate temperature readings. These devices are also known as telethermographic systems, infrared thermographs, thermal cameras, and…
Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped
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) HVAD Pump Implant Kits for the HeartWare HVAD System RMS (supplier) Lots: 8721869-001-01 8722375-001-01 8722375-002-02 Model: Medtronic HVAD Pump Implant Kits, labeled as:…
Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System
Summary Company Announcement Date: February 23, 2021 FDA Publish Date: February 23, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to endoleaks, stent fractures and stent ring enlargement Company Name: Medtronic Brand Name: Brand Name(s) Medtronic Valiant Navion™ Product Description: Product Description Thoracic stent graft system Company Announcement Medtronic plc (NYSE:MDT),…
Hillrom Recalls Liko Multirall 200 Overhead Lift Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook
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 Products Hillrom Liko Multirall 200 Overhead Lift Model Number, Product Codes, Catalog or Lot numbers: Liko Multirall 200 (product number 3130001) Universal SlingBar 450 R2R (product number…
Pulse Oximeter Accuracy and Limitations: FDA Safety Communication
Date Issued: February 19, 2021 The Coronavirus Disease 2019 (COVID-19) pandemic has caused an increase in the use of pulse oximeters, and a recent report (Sjoding et al.) suggests that the devices may be less accurate in people with dark skin pigmentation. The U.S. Food and Drug Administration (FDA) is informing patients and health care…
Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit
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) EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) Lots: See below Model: S-ICD A209 and MRI S-ICD A219 Distribution Dates: June 1, 2015 – September…
Adamssecret.co Issues Voluntary Nationwide Recall of Adam’s Secret Extra Strength 1500 and 3000 Capsules Due to Presence of Undeclared Sildenafil and/or Tadalafil
Summary Company Announcement Date: February 15, 2021 FDA Publish Date: February 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared sildenafil and/or tadalafil Company Name: Adamssecret.co Brand Name: Brand Name(s) Adam’s Secret Product Description: Product Description Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules Company Announcement…
Using Ventilator Splitters During the COVID-19 Pandemic – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is informing health care providers and health care facilities about up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters, in situations in which no alternatives for invasive ventilatory support are available. Although the FDA has not received any adverse event reports related to the use…