Summary Company Announcement Date: August 10, 2021 FDA Publish Date: August 10, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to waterborne microbial contamination Company Name: SterRx, LLC Brand Name: Brand Name(s) SterRx, LLC Product Description: Product Description Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Company Announcement SterRx, LLC…
Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Incorrect Transition to Safety Mode
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: INGENIO Family of Pacemakers and CRT-Ps (includes models ADVANTIO DR EL, INGENIO DR EL and VITALIO DR EL) Product Codes: LWP Model Numbers: J174, J177,…
Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum
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 Recirculator 8.0 Disposable Lavage Kit Product Code: 8100 Lot Numbers: 20021361, 20202106, 20202106, 20018480, 19854186, 20019438, 20018480, 19854186, 19854185, 20202106, 20019438, 19854184, 20202106, 20018480, 20202106, 20018480, 18687686…
Eco-Med Pharmaceutical Issues Voluntary Recall of Eco-Gel 200
Summary Company Announcement Date: August 04, 2021 FDA Publish Date: August 04, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product is contaminated with bacteria (Burkholderia cepacia complex) Company Name: Eco-Med Pharmaceutical Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Ultrasound Gel Company Announcement Etobicoke, Ontario (August 4, 2021)…
Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen
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 V60 Plus ventilators and all V60 ventilators upgraded to enable High Flow Therapy (software version 3.00 and 3.10) Distribution Dates: May 1, 2009 to June 2, 2021…
BD to Begin Remediation for BD Alaris™ System Software
Summary Company Announcement Date: July 29, 2021 FDA Publish Date: August 02, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Infusion pump may not operate as expected Company Name: Becton, Dickinson and Company Brand Name: Brand Name(s) Product Description: Product Description Alaris System Company Announcement FRANKLIN LAKES, N.J., July 29, 2021 /PRNewswire/…
Healthy Breakfasts for Kids: It’s All About Balance
[embedded content] Español A healthy breakfast is a must for kids. Skip it and your kids will be playing nutritional catch-up for the rest of the day, says Carole L. Adler, M.A., R.D., a dietitian at the Food and Drug Administration (FDA). When kids skip breakfast, they don’t get what they need to be at…
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinoma
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we have a quick update on another recent FDA cancer drug approval. On July 21, 2021, the FDA approved pembrolizumab (brand name…
Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions
Philips Respironics has voluntarily recalled certain ventilators, BiPAP, and CPAP machines due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain…
FDA D.I.S.C.O. Burst Edition: FDA approval of Rezurok (belumosudil) for adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we have a quick update on another recent FDA cancer drug approval. On July 16, 2021, FDA approved belumosudil (brand name Rezurock),…