Summary Company Announcement Date: December 09, 2023 FDA Publish Date: December 11, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to seal integrity issues allowing for powder leakage from the pouch. Company Name: InvaGen Pharmaceuticals Inc. Brand Name: Brand Name(s) Product Description: Product Description Vigabatrin for Oral Solution, USP 500mg Company Announcement…
Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive
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: CARDIOHELP Emergency Drive Product Codes: See Recall Database Entry Model Numbers: 701048002, 701076205 Manufacturing Dates: August 11, 2022 through June 20, 2023 Distribution Dates: September…
Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays
Summary Company Announcement Date: December 07, 2023 FDA Publish Date: December 07, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential lack of sterility assurance which could result in non-sterile product Company Name: Cardinal Health Brand Name: Brand Name(s) Covidien and Cardinal Health Product Description: Product Description Urology and OR room specific…
Cordis US Corp Recalls INFINITI Angiographic Catheter due to Products Being Shipped Without Undergoing Sterilization Procedures
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: Cordis INFINITI Angiographic Catheter Product Codes: DQO Lot Number: 18223410 Distribution Dates: August 21, 2023 to September 25, 2023 Devices Recalled in the U.S.: 30…
Antiseizure Medicines Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam): Drug Safety Communication – FDA Warns of Rare but Serious Drug Reaction
[Posted 11/28/2023] AUDIENCE: Patient, Health Professional, Neurology, Dermatology, Allergy and Immunology, Pharmacy ISSUE: The FDA is warning that the antiseizure medicines, Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction…
BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication – FDA Investigating Serious Risk of T-cell Malignancy
[Posted 11/28/2023] TOPIC: BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication – FDA Investigating Serious Risk of T-cell Malignancy AUDIENCE: Patient, Health Professional, Risk Manager, Oncology, Pharmacy ISSUE: The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous…
Baxter Issues Urgent Medical Device Correction for Novum IQ Syringe Infusion Pump Due to Potential Impact of Downstream Occlusions on Infusion Volume
Summary Company Announcement Date: November 29, 2023 FDA Publish Date: November 30, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for an incomplete infusion following one or more downstream occlusion alarms. Company Name: Baxter International, Inc. Brand Name: Brand Name(s) Product Description: Product Description Novum IQ syringe infusion pump. Company Announcement…
Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes
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: BD Alaris Syringe Module, BD Alaris PCU, and Alaris PCA Module Model Numbers: 8110, 8015, 8120 Distribution Dates: June 19, 2004 to September 22, 2023…
Eitan Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect Air in the Line
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 voluntary correction, not a product removal. Eitan Medical Ltd will be updating affected devices to address this issue. Recalled Product: Product Name:…
Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
Date Issued: November 30, 2023 The U.S. Food and Drug Administration (FDA) is informing consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China. The FDA is collecting and analyzing data to evaluate plastic…