Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to visible particulate Company Name: Hospira, Inc. Brand Name: Brand Name(s) Hospira, Inc. Product Description: Product Description Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial Company Announcement Hospira,…
Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency
Summary Company Announcement Date: April 29, 2021 FDA Publish Date: April 30, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Sub potency Company Name: Acella Pharmaceuticals, LLC Brand Name: Brand Name(s) Product Description: Product Description NP Thyroid (Thyroid Tablets, USP) Company Announcement Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the…
Pacific Medical Group (DBA Avante Health Solutions) 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 Front Bezel, purchased and/or installed by Pacific Medical Group (DBA Avante Health Solutions) Models: Alaris Model 8100 Serial Numbers: Please See…
Scentsational Soaps & Candles, Inc. Issues Voluntary Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde
Summary Company Announcement Date: April 28, 2021 FDA Publish Date: April 28, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde Company Name: Scentsational Soaps & Candles, Inc. Brand Name: Brand Name(s) Ulta Beauty Collection & SS Product Description: Product Description Scented Hand Sanitizer Company Announcement…
Cordis Recalls Precise PRO Rx US Carotid System Due to Risk of Separation in Device 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 Products Precise PRO Rx US Carotid System Product and Lot numbers: Full List of Affected Devices Manufacturing Dates: October 2019 to August 2020 Distribution Dates: December 6, 2019…
Tenacore LLC Issues Nationwide Recall of Tenacore’s Replacement for the Front Bezel Assembly of the CareFusion Alaris 8100 Infusion Pump Module
Summary Company Announcement Date: April 19, 2021 FDA Publish Date: April 19, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potentially weakened plastic Company Name: Tenacore LLC Brand Name: Brand Name(s) Tenacore LLC Product Description: Product Description 2001 Tenacore Replacement CareFusion Alaris 8100 bezels Company Announcement On February 24th, 2021, Tenacore LLC…
Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop
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 Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (Bio-Console 560) Models: 560BC, 560BCS, 560BC1, 560BCS1, R560BCS1 Serial Numbers: Please See Links Below. Distribution Dates: April 1, 2019 to…
BD Announces the Voluntary Recall of Specified Lots of ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator in the United States and U.S. Territories Due to Defective Applicator
Summary Company Announcement Date: April 20, 2021 FDA Publish Date: April 20, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Defective applicator Company Name: Becton, Dickinson and Company Brand Name: Brand Name(s) ChloraPrep Product Description: Product Description ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator Company Announcement BD (Becton, Dickinson and Company), a leading global…
Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly 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 Pumps serviced by Tenacore Models: Model 8100 Serial Numbers: Please See Link Below. Distribution Dates: July 10, 2020 to February 18, 2021 Devices Recalled in…
CareFusion 303, Inc. Recalls BD Alaris Pump Module Model 8100 Due to Risk of Stuck or Unresponsive Keys
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 BD Alaris Infusion Pump Module Affected Model Number: 8100 Affected Parts: 49000239; 49000346; 49000438; 49000439 Manufacturing Dates: 01/15/2019 to 12/05/2019. Distribution Dates: January 23, 2019 to December…