[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…
Meta Herbal Issues Voluntary Nationwide Recall of Magnum XXL 9800 Capsules Due to Presence of Undeclared Sildenafil
Summary Company Announcement Date: November 29, 2023 FDA Publish Date: November 29, 2023 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil Company Name: Meta Herbal Brand Name: Brand Name(s) Product Description: Product Description Magnum Male Sexual Enhancement XXL 9800 capsule Company Announcement FOR IMMEDIATE RELEASE – November 28, 2023 – E….
Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication
Date Issued: November 28, 2023 The U.S. Food and Drug Administration (FDA) is warning patients and health care providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The FDA recently received medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs…
Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization
Summary Company Announcement Date: November 24, 2023 FDA Publish Date: November 27, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to crystallization formation Company Name: Novartis Pharmaceuticals Corporation Brand Name: Brand Name(s) Product Description: Product Description Sandimmune (cyclosporine oral solution, USP) Oral Solution 100 mg/mL Company Announcement FOR IMMEDIATE RELEASE – November…
Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections
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: VariSoft Infusion Sets Product Codes: FPA Model Numbers: 1002827, 1002828, 1002830 Lot Numbers: 5388367; 5388357; 5388371; 5388362; 5388368; 5388366; 5388372; 5388376 Manufacturing Dates: April 1,…
Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder Due to the Presence of Benzene
Summary Company Announcement Date: November 24, 2023 FDA Publish Date: November 24, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of benzene Company Name: Insight Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal SprayPowder Company Announcement TARRYTOWN, N.Y., Nov. 24, 2023 (GLOBE NEWSWIRE) —…