BEUDAMED
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    100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.

    FDA Enforcement
    Class III ·Terminated·Steris Corporation·September 12, 2012

    Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·April 4, 2018

    KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired

    FDA Enforcement
    Class II ·Terminated·KT Health, LLC·April 29, 2020

    Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.

    FDA Enforcement
    Class II ·Terminated·J T Posey Company·April 17, 2013

    KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired

    FDA Recall
    Terminated ·KT Health, LLC·Product code IME·September 16, 2019

    Integra Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red; Container Lid, Size, Gold; Container Lid, Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.

    FDA Recall
    Terminated ·Integra York PA, Inc·Product code KCT·July 30, 2014

    Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8748, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Small 4 Latch, REF 50-8950, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Small 4 Latch, REF 50-8951, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Green Small 4 Latch, REF 50-8952, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Blue Small 4 Latch, REF 50-8953, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Red Small 4 Latch, REF 50-8954, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Black Small 4 Latch, REF 50-8955, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Medium Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8736, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8737, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8738, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8749, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8750, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8751, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Medium 4 Latch, REF 50-8956, 445mm x 279mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Medium 4 Latch, REF 50-8957, 445mm x 279mm, QTY: 1,

    FDA Recall
    Terminated ·Symmetry Medical/SSI·Product code KCT·December 5, 2013

    Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code GJT·May 11, 2015

    JS Series SterilContainer S2 System

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code KCT·September 8, 2017

    Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process. The instrument tray is a perforated stainless steel case with a latchable lid and handle. The tray is fitted with nylon coated aluminum holders, silicone instrument holders, and a protective mat. The instrument tray is marked to facilitate organized instrument placement.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code KCT·May 19, 2011

    symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP, C24136-SP, C24138-SP Product Usage: sterilization container

    FDA Recall
    Terminated ·Symmetry Surgical, Inc.·Product code KCT·November 29, 2016

    symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136 Product Usage: sterilization container

    FDA Recall
    Terminated ·Symmetry Surgical, Inc.·Product code KCT·November 29, 2016

    Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJT·January 28, 2013

    Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code GJT·July 8, 2005

    Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.

    FDA Recall
    Terminated ·PerkinElmer LIfe Sciences Inc·Product code JJT·January 8, 2003

    45cm Laparoscopic Instruments Sterilization tray. Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95138 Designed to hold laparoscopic surgical manual instruments which are intended for cutting, holding, grasping and manipulating tissue, organs, organ area, surgical auxiliaries such as suturing material. The 45cm Lap tray can hold up to 11 instruments in the top tier and a combination of instruments in the bottom tier provided that the total weight of the loaded tray does not exceed 6.53 kg.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code KCT·June 8, 2011

    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

    FDA Recall
    Terminated ·PMBS, LLC·Product code KCT·January 13, 2016

    symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-G, C22855-G, C22856-G, C22858-G, C24134-G, C24135-G, C24136-G, C24138, C24138-G Product Usage: sterilization container

    FDA Recall
    Terminated ·Symmetry Surgical, Inc.·Product code KCT·November 29, 2016

    STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code KCT·December 19, 2019

    STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code KCT·December 19, 2019