AUDIENCE: Patient, Rheumatology, Gastroenterology, Cardiology, Neurology, Oncology, Pharmacy, Health Professional ISSUE: The FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib) and Rinvoq (upadacitinib) to include information about the risks of serious heart-related events, cancer, blood clots, and death. Based on the review of a large randomized safety…
Magellan Diagnostics, Inc. Expands Voluntary Recall of LeadCare® Test Kits
Summary Company Announcement Date: September 01, 2021 FDA Publish Date: September 02, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples Company Name: Meridian Bioscience, Inc. Brand Name: Brand Name(s) Meridian Bioscience, Inc. Product Description: Product Description LeadCare®…
Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency
Summary Company Announcement Date: August 27, 2021 FDA Publish Date: August 30, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potency Company Name: Teligent Pharma, Inc. Brand Name: Brand Name(s) Product Description: Product Description Lidocaine HCl Topical Solution 4% Company Announcement Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl…
Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication
Date Issued: August 26, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Madison Avenue Radiology Center 190th Broadway, located in New York, New York, on or after February 26, 2019, about possible problems with the quality of their mammograms. Recommendations for Patients If you have had a more…
Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng – Letter to Health Care Providers
August 25, 2021 The U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff, and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. (Shanghai Dasheng). The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health…
Bio-Medical Equipment Service Co. Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
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 Alaris Infusion Pump Module Model 8100 Bezel purchased or installed by Bio-Medical Equipment Service Co. Models: Alaris Model 8100 Product Number: TIPA-8100-4410 Serial Numbers: See Recall Database…
Baxter Issues Urgent Medical Device Correction for All Spectrum IQ Infusion Pumps to Reinforce Important Safety Information Regarding Best Practices for Customer-Initiated IT Network Updates
Summary Company Announcement Date: August 24, 2021 FDA Publish Date: August 24, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Multiple Connectivity Errors Company Name: Baxter International Inc. Brand Name: Brand Name(s) Spectrum IQ Product Description: Product Description Infusion Pumps Company Announcement Baxter International Inc. announced today it has issued an Urgent…
Cardinal Health Recalls Monoject Saline Flush Prefilled Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism
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 Monoject Flush Prefilled Syringes (0.9% sodium chloride) Product Codes, All Lots: Product Code (SKU) – Product Description: 8881570121 – 12mL Syringe, 10mL Saline Fill 8881570123 – 12mL…
Cardinal Health Recalls Argyle UVC Insertion Tray Due to Missing Instructions for Use for the Safety Scalpel N11
The FDA 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 Name: Argyle UVC Insertion Tray containing Safety Scalpel N11Product Codes: Argyle UVC Insertion Tray (SKU 43201) and Safety Scalpel N11 (vendor part number 73-1811)Manufacturing Dates: August 13,…
Cardinal Health Issues Nationwide Recall of Select Monoject™ Flush Prefilled Saline Syringes
Summary Company Announcement Date: August 19, 2021 FDA Publish Date: August 20, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Products have been found to reintroduce air into the syringe after the air has been expelled Company Name: Cardinal Health Brand Name: Brand Name(s) Product Description: Product Description Flush Prefilled Saline Syringes…