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    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code MKJ·July 26, 2012

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code MKJ·July 26, 2012

    biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)

    FDA Recall
    Terminated ·Medtronic Emergency Response Systems, Inc.·Product code MKT·June 13, 2007

    BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTO·April 12, 0013

    BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers, incorrectly labeled in part ***Methylene Blue Loeffler***Becton Dickinson and Company***Packaged in Mexico*** Lactophenol cotton blue is a blue stain used for direct examination of clinical specimens for fungal elements.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JTO·September 28, 2009

    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci

    FDA Recall
    Terminated ·Remel Inc·Product code JTO·May 2, 2013

    Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.

    FDA Recall
    Terminated ·Remel Inc·Product code JTO·May 2, 2013

    Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338

    FDA Recall
    Terminated ·Hardy Media Inc Dba Hardy Diag·Product code JTO·December 31, 2003

    Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic observation.

    FDA Recall
    Terminated ·Gibson Bioscience·Product code JTO·July 1, 2021

    BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTO·April 12, 0013

    Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JTO·March 23, 2018

    HARDY DIAGNOSTICS CatScreen, 25dsk/vial

    FDA Recall
    Terminated ·MEDLINE INDUSTRIES, LP Northfield·Product code JTO·December 1, 2021

    Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FRN·March 23, 2012

    Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.

    FDA Recall
    Terminated ·Widex A/S Nymollevej 6 Lynge Denmark·Product code ESD·August 31, 2018

    IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.

    FDA Recall
    Terminated ·Intelerad Medical Systems 895 Rue De La Gauchetiere O Montreal Canada·Product code LLZ·July 3, 2014

    PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL

    FDA Recall
    Terminated ·DiaDexus, Inc·Product code NOE·July 18, 2008

    Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.

    FDA Recall
    Terminated ·Atos Medical AB Kraftgatan·Product code BYD·March 29, 2021

    VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JIT·May 12, 2014

    VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF).

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DHR·November 10, 2011

    Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger, multi-site, Patient range adult to neonatal, memory function Approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hours, size: 42x68x20mm, weight 42g.

    FDA Recall
    Terminated ·Minolta Corp·Product code DQA·November 14, 2003