BEUDAMED
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    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 24, 2014

    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GWM·November 7, 2014

    Case Label: McKesson Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-104 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc 1 - Thumb Control Ring Piston Syringe (Catheter Tip), 60 cc 1- Graduated Solution Container, 500 cc, 1 - Underpad, 1-Sterile Alcohol Prep Pad Reorder No. 37-104 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Intended use: The trays are irrigation trays for catheters

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-103 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use Disposable Latex-Free Contents: 1 - Graduated Tray, 1200 cc 1 - Green Bulb Syringe (Catheter Tip), 60 cc 1 - Graduated Solution Container, 500 cc 1- Underpad, 1 - Sterile Alcohol Prep Pad Reorder No. 37-103 Contents STERILE in unopened, undamaged package. Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Usage: The trays are irrigation trays for catheters

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

    FDA Enforcement
    Class II ·Terminated·CSA Medical·April 29, 2015

    CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

    FDA Recall
    Terminated ·Product code GEH·March 25, 2015

    (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P1 Combined Oxygen & Temperature Probe. Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GWM·February 18, 2010

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    FDA Enforcement
    Class II ·Terminated·CSA Medical·January 14, 2015

    Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNL·November 16, 2005

    Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005

    Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNL·January 1, 2006

    (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·December 22, 2017

    Licox Brain PMO Probe Kit; Ref IP2.P; Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe; Contains sterile and non-pyrogenic if package is unopened and undamaged. Integra US, 311 Enterprise Drive, Plainsboro, NJ 08536

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GWM·September 15, 2010

    Case Label: McKESSON Medi-Pak Urethral Catheter Tray With Plastic Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON LATEX FREE Medi-Pak Urethral Catheter Tray With Plastic Catheter Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc, 1-Pair of Vinyl Gloves, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Specimen Container with Lid and Label, 1-Polylined Drape, 1-Pack of Lubricating Jelly, 1-14 FR Plastic Catheter Reorder No. 37-231 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    Case Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc, 1-Pair of Vinyl Gloves, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Specimen Container with Lid and Label, 1-Polylined Drape, 1-Pack of Lubricating Jelly, 1-30 cc Syringe, Pre-Filled with Sterile Water Reorder No. 37-234 Contents STERILE In unopened, undamaged package. Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    FDA Recall
    Terminated ·Product code GEH·November 10, 2014

    Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CCH·June 12, 2006

    Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA

    FDA Recall
    Terminated ·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006

    Portex Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CAZ·September 23, 2013