32 results · 13ms · Sources: EU EUDAMED, US FDA

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KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

FDA Recall
Terminated ·Mc-NEIL-PPC, Inc.·Product code NUC·January 25, 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

KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

FDA Recall
Terminated ·Mc-NEIL-PPC, Inc.·Product code NUC·January 25, 2013

KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.

FDA Recall
Terminated ·Mc-NEIL-PPC, Inc.·Product code NUC·January 25, 2013

ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.

FDA Recall
Terminated ·Memphis Fertility Laboratory Inc·Product code NUC·July 10, 2009

Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to facilitate insertion of diagnostic or therapeutic devices during fertility interventions such as: embryo transfer, transvaginal collection of oocytes, intrauterine insemination and post coital testing. In addition, product may be used as a personal lubricant to supplement the body's own natural lubricating fluids.

FDA Recall
Terminated ·INGfertility, LLC·Product code NUC·September 22, 2008

Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300. The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation.

FDA Recall
Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code BYD·April 29, 2011

Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box

FDA Recall
Terminated ·DeRoyal Surgical Tray·Product code NAC·January 19, 2004

Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).

FDA Recall
Terminated ·Alere San Diego, Inc.·Product code NBC·May 22, 2012

Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.

FDA Recall
Terminated ·Alere San Diego, Inc.·Product code NBC·May 22, 2012

i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.

FDA Recall
Terminated ·Abbott Point Of Care Inc.·Product code NBC·February 1, 2012

VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK

FDA Recall
Terminated ·ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom·Product code NBC·March 7, 2017

Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code NBC·April 5, 2012

Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.

FDA Recall
Terminated ·Alere San Diego, Inc.·Product code NBC·May 22, 2012

Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) as an aid in the assessment of severity of congestive heart failure for the risk stratification of patients with acute coronary syndromes for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.

FDA Recall
Terminated ·Alere San Diego, Inc.·Product code NBC·May 30, 2014

Stratus CS STAT Fluorometric Analyzer Acute Care pBNP DilPak (CpBNP-D) in vitro diagnostic.

FDA Recall
Terminated ·Dade Behring Inc.·Product code NBC·April 3, 2006

VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.

FDA Recall
Terminated ·Biomerieux France Chemin De L'Or Chemin De L'Orme Marcy L'Etoile France·Product code NBC·April 15, 2016

Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·July 25, 2012

The Quidel Triage BNP Calibrators

FDA Recall
Terminated ·Medline Industries Inc·Product code NBC·October 1, 2020

PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

FDA Recall
Terminated ·Polymedco, Inc., Polymedco Cancer Diagnostic Products, Llc·Product code NBC·April 30, 2018