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 HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Model Numbers: HVAD™ Pump Outflow Graft: 1125 HVAD™ Pump Implant Kit: 1103 HVAD™ Implant Accessories Kit: 1153…
Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) reminds reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the COVID-19 pandemic. ASP STERRAD Sterilization Systems use vaporized hydrogen…
Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency
Summary Company Announcement Date: May 22, 2020 FDA Publish Date: May 22, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potency Company Name: Acella Pharmaceuticals, LLC Brand Name: Brand Name(s) Product Description: Product Description 30-mg, 60-mg and 90-mg NP Thyroid® Company Announcement Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13…
Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval
Summary Company Announcement Date: May 20, 2020 FDA Publish Date: May 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Unapproved new drug Company Name: Biota Biosciences, LLC Brand Name: Brand Name(s) Biota Biosciences Product Description: Product Description Cannabidiol (CBD) Complex, Curcumin Complex, Cannabidiol + Curcumin Company Announcement Biota Biosciences is voluntarily recalling…
Summitt Labs Issues Voluntary Nationwide Recall of KORE ORGANIC Watermelon CBD Oil Due to High Lead Results
Summary Company Announcement Date: May 12, 2020 FDA Publish Date: May 15, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains lead Company Name: Summitt Labs Brand Name: Brand Name(s) KORE ORGANIC Product Description: Product Description Watermelon CBD oil tincture Company Announcement Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon…
Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use
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 Python Embolectomy Catheters, Bard Embolectomy Catheters, and the OTW Latis Cleaning Catheters Model Numbers: Python Embolectomy Catheters: A4E01, A4E02, A4E03, A4E04, A4E05, A4E06, A4E08, A4E09 Bard Embolectomy…
MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypertensive Drug
Summary Company Announcement Date: May 06, 2020 FDA Publish Date: May 11, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains undeclared minoxidil Company Name: MasterPharm, LLC Brand Name: Brand Name(s) MasterPharm, LLC Product Description: Product Description Finasteride Plus 1.25mg, capsules Company Announcement MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus…
Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) has become aware of the potential for health care facility staff that reprocess and sterilize medical devices to misinterpret the indicators used to validate the sterilization of medical devices because there is no standard indicator color to indicate a sterilized device. Health care facilities alerted the FDA that,…
ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer’s Injection, USP Due to the Presence of Particulate Matter
Summary Company Announcement Date: May 08, 2020 FDA Publish Date: May 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulates (iron oxide) Company Name: ICU Medical Inc. Brand Name: Brand Name(s) ICU Medical Inc. Product Description: Product Description Lactated Ringer’s Injection, USP Company Announcement ICU Medical, Inc. is voluntarily recalling…
Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is concerned that certain filtering facepiece respirators (respirators) from China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 based on additional filtration performance testing conducted by the National Institute for Occupational Safety and Health (NIOSH) – National Personal Protective Technology Laboratory…