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    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.

    FDA Enforcement
    Class II ·Terminated·Advandx Inc·October 31, 2012

    Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L and M This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.

    FDA Recall
    Terminated ·Picis Inc.·Product code NSX·August 1, 2011

    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.

    FDA Recall
    Terminated ·Advandx Inc·Product code JSS·September 14, 2012

    EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X 4" LIF (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF ( I) SH EET ENT SPLIT 11 0 X 77 (2) LITE GLOVE (2) NEEDLE H YPODERM IC 27G X I \!..'' (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF ( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF (4) COTrON APPLICATOR 6" WOOD ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED LIF ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF ( I ) TRAY MAYO SMALL ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF ( I ) DRAPE MICROSCOPE ZEI SS ( I ) TOWELS ABSORBENT 1 5'' X 20" LIF ( I ) TIME OUT BEACON NON WOV EN ST LIF ( I ) BLADE M INUATURE CARBON STEEL ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, (2) SCALPEL SAFETY WEIGHTED # 1 5 ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF ( I ) WRAPPER 24" X 24" WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30" ( I ) TRAY 3/COMPARTM ENT ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE (3) TI P ABSORBENT APPLICATOR STICK SPONGE (3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF (2) GLOVE MED FREETOUCI-1 VYN I L P/F (2) COTrON APPLICATOR 6" WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in a iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KQO·March 29, 2018

    EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X 4" LIF (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF ( I) SH EET ENT SPLIT 11 0 X 77 (2) LITE GLOVE (2) NEEDLE H YPODERM IC 27G X I \!..'' (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF ( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF (4) COTrON APPLICATOR 6" WOOD ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED LIF ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF ( I ) TRAY MAYO SMALL ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF ( I ) DRAPE MICROSCOPE ZEI SS ( I ) TOWELS ABSORBENT 1 5'' X 20" LIF ( I ) TIME OUT BEACON NON WOV EN ST LIF ( I ) BLADE M INUATURE CARBON STEEL ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, (2) SCALPEL SAFETY WEIGHTED # 1 5 ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF ( I ) WRAPPER 24" X 24" WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30" ( I ) TRAY 3/COMPARTM ENT ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE (3) TI P ABSORBENT APPLICATOR STICK SPONGE (3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF (2) GLOVE MED FREETOUCI-1 VYN I L P/F (2) COTrON APPLICATOR 6" WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OGR·May 20, 2014

    15776-20 REG ANES W/DRUGS

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004

    15548-20 REG ANES W/DRUGS

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004

    Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerate. GmbH & Co. KG for Ziehm Imaging GmbH Germany, and used with Ziehm Imaging GmbH Mobile C-arm as a component thereof. Two versions were made: 2 pedal version KF 2 1S/1 S-MED-AP foot switch and 4 pedal foot switch version KF 2 1S/1 S-MED-AP This type of foot switch includes a pair of the dual foot switches assembled on a single metal bracket. The following labels may appear on the foot switch: Labeled in part: "Fluoro- Store***ZIN Part no. # 58371***ZIR Part no. # 10-2985*** Left Pedal: Initiate Radiation***Right Pedal: Store Image***" Labeled in part: "Fluoro - Cine***ZIN Part no. # 58415***ZIR Part no. # 10-2987*** Left Pedal: Initiate Radiation***Right Pedal: Switch into Cine mode***" Labeled in part: "Fluoro - Mag***ZIN Part no. # 58413***ZIR Part no. # 10-2989*** Left Pedal: Initiate Radiation***Right Pedal: Switch through magnification***" Labeled in part: "Fluoro -Snap***ZIN Part no. # 58417***ZIR Part no. # 10-2991*** Left Pedal: Initiate Radiation ***Right Pedal: Initiate Snapshot***" Labeled in part: "DSA - CINE***ZIN Part no. # 58419***ZIR Part no. # 10-2993*** Left Pedal: Switch into DSA mode ***Right Pedal: Switch into Cine mode***" Labeled in part: "Cine - Store***ZIN Part no. # 58421***ZIR Part no. # 10-2995*** Left Pedal: Switch into Cine mode***Right Pedal: Store Image***" Labeled in part: "Cine - LONG:Endo ON/OFF & SHORT:Freeze*** ZIN Part no. # 58423***ZIR Part no. # 10-2997*** Left Pedal: Switch into Cine mode***Right Pedal: Long: Switch Endo On/Off Short: Freeze the endoscopic image on live screen***" Labeled in part: "Cine- Endo ON /OFF***ZIN Part no. # 58425***ZIR Part no. # 10-2999*** Left Pedal: Switch into Cine mode***Right Pedal: Switch Endo On / Off***" Labeled in part: "Fluoro - Swap***ZIN Part no. # 58427***ZIR Part no. # 10-3031*** Left Pedal: Initiate Radiation***Right Pedal: Swaps the image between the live and reference screens***" Labeled in part: "DSA / MSA/RSA - OFF***ZIN Part no. #58429***ZIR Part no. #10-3033***Left Pedal: Switch DSA/MSA/RSA On***Right Pedal: Switch DSA/MSA/RSA Off***" The KF 2 1S/1S-MED- AP foot switch is a component of the Mobile C-arm and is used by the physician to activate Fluoroscopic X-Ray for imaging by pressing the foot switch.

    FDA Recall
    Terminated ·Ziehm Imaging Inc·Product code JAA·April 29, 2011

    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·June 11, 2014

    Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 3, 2018

    Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·August 7, 2019

    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System

    FDA Enforcement
    Class II ·Terminated·Cook Medical Incorporated·February 3, 2016

    1 Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor Part Number: 720059B, Medline Item Number: 40056; Available in various Anesthesia Circuit Kits and Complete Delivery System kits including: 1) Item Number CDS980230I, NICU-OR CDS; 2) Item Number DYNJ22691, Basin Supply Pack; 3) Item Number DYNJ24724, Spine-Crani Anesthesia Kit; 4) Item Number DYNJAAHY11, Hyperinflation System-UHS-1L; 5) Item Number DYNJAP0010, Anesthesia Circuit Ped-LF; 6) Item Number DYNJAP0011A, Pediatric Circuit-LF; 7) Item Number DYNJAP0012, Pediatric Anesthesia 40 In. CI; 8) Item Number DYNJAP0100, Pedi Breathing Circuit-LF; 9) Item Number DYNJAP0101, Anesthesia Circuit-Ped; 10) Item Number DYNJAP4012, Anesthesia Circuit Ped; 11) Item Number DYNJAP4013, Anesthesia Circuit; 12) Item Number DYNJAP4702A, Anesth Circuit Ped GS Line; 13) Item Number DYNJAP4707, Anesth Circuit 40in Ped-LF; 14) Item Number DYNJAP4722, Anes Cir 40 Ped GSEPW HYBABYH; 15) Item Number DYNJAP4729A, Circ Ped Anes Super-LF; 16) Item Number DYNJAP4730A, Circuit Pediatric Anesthesia; 17) Item Number DYNJAP4732, Anesth Circ Ped 40in 2B/V; 18) Item Number DYNJAP4740, Anesth Circ 40in Ped; 19) Item Number DYNJAP6101, Anesthesia Circuit; 20) Item Number DYNJAP6105, Anesth Circuit 60in Ped; 21) Item Number DYNJAP6106, Anes Circ Ped 60in BI GSE-LF; 22) Item Number DYNJAP6107, Anesth Circ Ped 60in ANG HME; 23) Item Number DYNJAP6108, Anesth Circuit 60in Ped; 24) Item Number DYNJAP6109, Anesth Circ Ped 60in B/V 1L-LF; 25) Item Number DYNJAP6111, Anes Cir Ped 60 GSEPW PALL FIL; 26) Item Number DYNJAP6112, Anesthesia-Peds Circuit; 27) Item Number DYNJAP6113, Circuit Pedi 60in; 28) Item Number DYNJAP6114, Anesth Circ 60in Ped; 29) Item Number DYNJAP6116, Anesth Circ 60in Ped; 30) Item Number DYNJAP6120A, Pediatric Circuit 40in LF; 31) Item Number DYNJAP6124, Anesth Circ Pedi 60in 1L GSL; 32) Item Number DYNJAP6127, Anes Circ Pedi 60in-LF; 33) Item Number DYNJAP6130, Anesth Circ Ped 60in 1L-LF; 34) Item Number DYNJAP6132A, Circuit Pediatric Anesthesia; 35) Item Number DYNJAP6133, Anesth Circuit Peds 60in-LF; 36) Item Number DYNJAP6136, Circuit Peds Anesthesia; 37) Item Number DYNJAP6137, Circuit Pediatric Anesthesia; 38) Item Number DYNJAP7217A, Anesth Circuit 72in Exp Ped BI; 39) Item Number DYNJAP7225A, Circuit Pediatric Anesthesia; 40) Item Number DYNJAP7227, Anes. 90in Exp Pedi -LF; 41) Item Number DYNJAP7233, Anes. Circuit 90in Exp Pedi-LF; 42) Item Number DYNJAP7234A, Anesthesia 72in Pediatric Exp; 43) Item Number DYNJAP7235A, Anesth Circ 72in Ped; 44) Item Number DYNJAP7236A, Anesthesia Pedi 72in; 45) Item Number DYNJAP7237, Circuit Pedi 90in EXP; 46) Item Number DYNJAP7241A, Circuit Pediatric Anesthesia; 47) Item Number DYNJAP7243B, Circ Anesth Ped 2 B/V LFree; 48) Item Number DYNJAP7246C, Circuit Pediatric Anesthesia; 49) Item Number DYNJAP7247, Anes Circ Peds 90in Exp; 50) Item Number DYNJAP7248, Anesth Circ Ped 72in Exp; 51) Item Number DYNJAP7261, Circuit Pediatric Anesthesia; 52) Item Number DYNJAP7262, Circuit Pediatric Anesthesia; 53) Item Number DYNJAP7263, Pediatric Anesthesia Circuits; 54) Item Number DYNJAP9005, Anesthesia Circuit; 55) Item Number DYNJAP9721A, Anesth Circuit Pedi HMEF LF; 56) Item Number DYNJAP9725, Pedi Expand Circuit; 57) Item Number DYNJAP9726, Anesth Circ Ped 90in; 58) Item Number DYNJAP9729, Anesth Circ 90in Exp Ped; 59) Item Number DYNJAP9730A, Circuit Pediatric 60in CORR-LF; 60) Item Number DYNJAP9732A, Circuit Pediatric Anesthesia; 61) Item Number DYNJAP9735, Peds Circuit; 62) Item Number DYNJAP9739, Circuit Pediatric Anesthesia; 63) Item Number DYNJAP9740, Circuit Pediatric Anesthesia; 64) Item Number DYNJAP9743, Circuit Pediatric Anesthesia; 65) Item Number DYNJAPF6003, Anesth Circ 60in Ped Unilimb; 66) Item Number DYNJAPF6005A, Anesth Circ 60in Uni Peds; 67) Item Number DYNJAPF6006, Anes Circ Peds 60in Uni; 68) Item Number DYNJAPF6009, Peds Anesthesia Circuit-LF; 69) Item Number DYNJAPF6011, Circuit Pediatric Anesthesia; 70) Item Number DYNJAPF601

    FDA Recall
    Terminated ·Medline Industries Inc·Product code BTC·December 7, 2007

    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·June 11, 2014

    CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·October 10, 2018

    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health Inc.·May 27, 2020

    Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·December 28, 2016

    GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 19, 2014

    Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).

    FDA Enforcement
    Class II ·Terminated·Ossur North America Inc·November 27, 2013