BEUDAMED
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    E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code OAH·June 8, 2010

    LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·March 29, 2011

    LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration. Product Usage: The LOGIX OE application is an order entry system intended for use with Baxters LOGIX CM software. The software program aids the pharmacist in creating and authorizing nutritional solution orders.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·August 15, 2011

    Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDT·April 21, 2021

    BF-3C40 OES Bronchofiberscope, Model No. BF-3C40

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021

    BF-P60 OES Bronchofiberscope, Model No. BF-P60

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021

    BF-XP60 OES Bronchofiberscope, Model No. BF-XP60

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOX·August 16, 2021

    BF-1T60 OES Bronchofiberscope, Model No. BF-1T60

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021

    BF-N20 OES Bronchofiberscope, Model No. BF-N20

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021

    Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631, 2066066, 6066803 and 20666941 with optional , Stryker Medical, Portage, MI 49002. Intended to provide the patient greater comfort and a sense of security.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code FPP·October 31, 2011

    Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·March 28, 2008

    "***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-0250***50 UNITS***STERILE OE***LATEX-FREE***LEVENTON LEVENTON, S.A.U. C/Newton, 18-24 08635 Sant Esteve Sesrovires BARCELONA-SPAIN***Distributed by: Victus www.victus.com 4918 S.W. 74th Court Miami, FL 33155***" To control intravascular infusion of medication.

    FDA Recall
    Terminated ·Leventon S. A. U. C/ Newton, 18-24 Sant Esteve Sesrovires Barcelona Spain·Product code LDR·March 11, 2011

    Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·November 17, 2008

    External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·November 17, 2008

    AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices in Healthcare Facilities.

    FDA Recall
    Terminated ·Steris Corporation·Product code MLR·July 26, 2018

    Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OES·October 26, 2018

    CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OES·April 24, 2019

    CVC BUNDLE, 20CM, 3L, PI ECVC5120

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OES·April 24, 2019

    CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OES·April 24, 2019

    CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OES·April 24, 2019