Department of JusticeU.S. Attorney’s OfficeEastern District of Virginia FOR IMMEDIATE RELEASETuesday, August 24, 2021 ALEXANDRIA, Va. – An Inverness, Florida, man was sentenced today to three years in prison for selling hundreds of thousands of counterfeit prescription drug pills through the Internet. “By selling counterfeit drugs through the Darknet, the defendant recklessly endangered the community…
Jimbo’s Kitchen, DBA New England Cupboard Issues Allergy Alert on Jimbo’s Bloody Mary Mix
Summary Company Announcement Date: August 24, 2021 FDA Publish Date: August 25, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Soy, Wheat, & Sulfites Company Name: Jimbo’s Brand Name: Brand Name(s) Jimbo’s Kitchen dba New England Cupboard Product Description: Product Description Bloody Mary Mix Company Announcement Jimbo’s Kitchen, DBA New…
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…
Loki Fish Company Recalls Keta Salmon Lox Because of Possible Health Risk
Summary Company Announcement Date: August 23, 2021 FDA Publish Date: August 23, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Loki Fish Company Brand Name: Brand Name(s) Loki Fish Co. Product Description: Product Description Keta Salmon Lox Company Announcement Loki Fish Company of Seattle, Washington is recalling…
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…
UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication
Date Issued: August 20, 2021 The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In addition, the FDA is aware of allegations…
Connecticut Nurse Sentenced for Tampering with Liquid Morphine
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEWednesday, August 18, 2021 Defendant replaced and diluted morphine prescribed to a hospice patient, for her own use BOSTON – A Connecticut nurse was sentenced today in federal court in Springfield for tampering with liquid morphine prescribed to a patient. Danielle Works, 42, of Stafford Springs,…