BEUDAMED
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    (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE

    FDA Enforcement
    Class II ·Terminated·Hill-Rom, Inc.·March 23, 2022

    Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012

    FDA Recall
    Terminated ·Bacterin International, Inc.·Product code MBP·April 18, 2012

    Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012

    FDA Enforcement
    Class II ·Terminated·Bacterin International, Inc.·February 20, 2013

    syngo Imaging XS. Radiological image processing system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·July 18, 2012

    8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician.

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code LJT·April 12, 2012

    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·November 12, 2012

    Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWT·May 12, 2012

    Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·June 12, 2012

    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code JPA·June 15, 2012

    Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. Product Usage: : Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: The Anti-Torque Key allows the Torque Wrench to align with the tightening axis and maximizing the torque needed to lock the implant assembly during final tightening of the spinal construct.

    FDA Recall
    Terminated ·Stryker Spine·Product code NKB·January 12, 2012

    Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

    FDA Recall
    Terminated ·Nipro Diagnostics, Inc.·Product code NBW·February 25, 2013

    The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code FPO·October 11, 2012

    Zimmer Spine Ardis Inserter, Rx, non-sterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code MAX·November 12, 2012

    Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JMG·May 6, 2013

    SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).

    FDA Recall
    Terminated ·Sentec AG Ringstrasse 39 Therwil, Baselland Switzerland·Product code LKD·July 9, 2012

    Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 14203-28. Intended use: for the administration of blood products.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FPA·January 12, 2012

    Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling Lines: OmniLine O2 Adult Part No.007609; OmniLine O2 Pediatric Part No 007610; Smart OmniLine Plus O2 Adult Part No.010177; Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213; Smart OmniLine O2 Pediatric Part No. 007606; ;Smart OmniBloc O2 Part No. 010946 Smart OmniLine Plus part No. 010172 Smart OmniLine Plus (package of 100 units) Part No 010212; Smart OmniLine Guardian O2 Part No. 012531; Smart OmniLine Guardian O2 Long Part No. 012532 OmniVentLine Set Part No. 012495

    FDA Recall
    Terminated ·Oridion Medical·Product code CCK·February 16, 2012

    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

    FDA Recall
    Terminated ·Horiba Instruments, Inc dba Horiba Medical·Product code JQP·September 20, 2012

    syngo.plaza, Model number 10592457. Intended use: radiological image processing system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·July 18, 2012

    DUET TRS 60 4.8MM STRAIGHT SULU Product Code: DUET6048 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

    FDA Recall
    Terminated ·Product code GDW·January 12, 2012