11 results
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46ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
FDA Recall
Terminated
·GSK Consumer Healthcare·Product code N/A·April 25, 2016
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
FDA Enforcement
Class III
·Terminated·GSK Consumer Healthcare·July 20, 2016
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
FDA Recall
Terminated
·Baxter Corporation Englewood·Product code FMF·December 21, 2015
ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609
FDA Recall
Terminated
·Pfizer Global·Product code IMD·September 24, 2010
3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog # 434-10. 3M Consumer Health Care, St. Paul, MN 55144-1000. Made in USA. UPC 05113166774.
FDA Recall
Terminated
·Product code FRL·February 9, 2006
Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth
FDA Recall
Terminated
·GlaxoSmithKline, LLC.·Product code LFD·October 17, 2013
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
FDA Recall
Terminated
·Mc-NEIL-PPC, Inc.·Product code NUC·July 2, 2012
DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.
FDA Recall
Terminated
·DeVilbiss Healthcare LLC·Product code JCX·March 7, 2013
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
FDA Recall
Terminated
·Philips Medical Systems, Inc.·Product code MHX·May 22, 2014
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
FDA Recall
Terminated
·Medtronic Inc.·Product code MDS·July 15, 2020
Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.
FDA Recall
Terminated
·Maquet Datascope Corp Cardiac Assist Division·Product code FMZ·March 16, 2011