The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2021 Safety Communications Content current as of: 01/04/2021 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/safety-communications/2021-safety-communications
Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol
Summary Company Announcement Date: January 04, 2021 FDA Publish Date: January 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Contaminated with Methanol Company Name: Essaar Inc. Brand Name: Brand Name(s) Soho Fresh Product Description: Product Description 70% Rubbing Alcohol Company Announcement Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70%…
Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
Date Issued: January 4, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Risks to a patient of a false negative result include: delayed or lack of supportive treatment, lack of monitoring of infected…
Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination
Summary Company Announcement Date: December 31, 2020 FDA Publish Date: December 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia lata Company Name: Precision Dose Inc. Brand Name: Brand Name(s) GUM Paroex Product Description: Product Description Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups Company Announcement Precision…
Sunstar Americas Inc. Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination
Summary Company Announcement Date: December 28, 2020 FDA Publish Date: December 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia lata Company Name: Sunstar Americas, Inc. Brand Name: Brand Name(s) Product Description: Product Description Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz Company Announcement Schaumburg, Illinois, Sunstar…
UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication
Date issued: December 29, 2020 The U.S. Food and Drug Administration (FDA) is updating our February 2020 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures. On December 29, 2020, the FDA issued the final guidance, Product Labeling for Laparoscopic Power…
Shane Erickson, Inc. DBA Innovative Marketing Consultants Issues Voluntary Nationwide Recall of Wash-Free Hand Sanitizer Due to Potential Presence of Undeclared Methanol
Summary Company Announcement Date: December 23, 2020 FDA Publish Date: December 23, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Methanol Company Name: Shane Erickson, Inc. DBA Innovative Marketing Consultants Brand Name: Brand Name(s) Product Description: Product Description Wash-Free Hand Sanitizer Company Announcement Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and…
Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device
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 Flexor Check-Flo Introducers Catalog and Lot numbers: See Full List Manufacturing Dates: February 17, 2020 to September 29, 2020 Distribution Dates: May 23, 2020 to November 17,…
Weight Loss, Male Enhancement and Other Products Sold Online or in Stores May Be Dangerous
Image Whether you’re looking to buy weight loss, male enhancement, or certain other products, these days you’re apt to look for them online, rather than at a physical store. But buyer, beware. When you buy such products, you may actually be getting an illegal product; and that product may contain potentially dangerous ingredients that are…
Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting you that Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious injury while used for removing clots in stroke patients. All users…