FDA daily for Tuesday, March 4, 2025
In this issue: 6 approvals, 2 device recalls, 19 device decisions and 87 label changes. 4 items touch categories MedGrid carries, and they come first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
- RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
Smith & Nephew Medical, Ltd. · General, Plastic Surgery
- Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)
Basic Medical Technology, Inc. · General Hospital
- Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30
TITANIUM DIOXIDE, ZINC OXIDE · Kenvue Brands LLC · TOPICAL
Drug and biologic approvals
FDA date:On Tue, Feb 25 FDA approved 1 new application (0 brand or biologic, 1 generic) and 5 supplements to existing ones.
- BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
CAPLIN · BRIMONIDINE TARTRATE, TIMOLOL MALEATE
Device recalls
FDA date:FDA posted 2 device recalls from 2 firms on Tue, Feb 25.
- LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Physio-Control, Inc. · Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
- DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. · Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assay…
Device clearances and approvals
FDA date:FDA decided 6 510(k)s and 13 PMA decisions on Tue, Feb 18.
- RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
Smith & Nephew Medical, Ltd. · General, Plastic Surgery
- Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)
Basic Medical Technology, Inc. · General Hospital
- FIX-C 3D Ti ACIF System
Jeil Medical Corporation · Orthopedic
- AXS Lift Intracranial Base Catheter
Stryker Neurovascular · Cardiovascular
- Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
Microport Orthopedics, Inc. · Orthopedic
- 0.04 ZERO ZERO FOUR Male Latex Condom
Okamoto USA, Inc. · Obstetrics/Gynecology
Label updates
FDA date:87 drug labels took effect on Tue, Feb 18; 3 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30
TITANIUM DIOXIDE, ZINC OXIDE · Kenvue Brands LLC · TOPICAL
- QIDILA Whitening Skin Lightening Cream
BUTYLENE GLYCOL,BUTYROSPERMUM PARKII (SHEA BUTTER),KYOUNIN YU,TOCOPHEROL,ASCORBIC ACID,NIACINAMIDE · Beijing JUNGE Technology Co., Ltd. · EXTRACORPOREAL
- Carbamazepine
CARBAMAZEPINE · A-S Medication Solutions · ORAL
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
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