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    CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels is needed.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·December 7, 2011

    TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Recall
    Terminated ·American Optisurgical Inc·Product code LFL·April 30, 2013

    iVIEW DAB Detecion Kit. Catalog Number 760-091

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code KTO·May 7, 2003

    SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.

    FDA Recall
    Terminated ·Vitrolife Inc·Product code KTO·December 22, 2014

    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code MWI·July 17, 2014

    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code MWI·July 17, 2014

    Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following products: Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalog #IS830MAN; Custom Tap Sleeve, Mantis - Catalog #IS2271MAN; and Custom Mantis Modular Tap Set - Catalog #IS2080MAN The Mantis Tap Sleeves with Markers was designed to be used in a manner identical to the predicate Standard Mantis Tap Sleeve 48281315. It is to be used in conjunction with Standard Mantis Cannulated Modular Taps: 1) to protect soft tissue from the cutting edge of the tap 2) to indicate the depth at which the Tap has been inserted.

    FDA Recall
    Terminated ·Stryker Spine·Product code LXH·January 7, 2011

    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

    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY

    FDA Recall
    Terminated ·Helena Laboratories, Inc.·Product code JPB·February 24, 2017

    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

    HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSO·June 24, 2015

    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

    Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.

    FDA Recall
    Terminated ·Symbios Medical Products, LLC·Product code MEB·May 10, 2013

    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FGE·December 18, 2013

    Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSI·March 4, 2015

    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

    SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.

    FDA Recall
    Terminated ·Ciba Vision Corporation·Product code LPN·September 27, 2004

    Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.

    FDA Recall
    Terminated ·Snug Seat Inc·Product code IOR·August 26, 2013

    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

    "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x 15mL Stopping Solution, 1 x 30mL Phosphate Buffered Saline, 1 x 2mL Free Protein S Reagent FOR IN-VITRO DIAGNOSTIC USE LOT: 3-16- 5292 EXP: 2018-01-26 HELENA LABORATORIES BEAUMONT, TX Outer labeling of Substrate (brown bottle and cap): "Substrate 13 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26" Outer Labeling of Protein S Conjugate bottle (clear bottle and cap, red liquid): "Protein S Conjugate 12 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26"

    FDA Recall
    Terminated ·Helena Laboratories, Inc.·Product code GGP·April 4, 2017