BEUDAMED
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    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Enforcement
    Class II ·Terminated·Paa Laboratories Inc·July 24, 2013

    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

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Recall
    Terminated ·Paa Laboratories Inc 145 Bethridge Road Etobicoke Canada Ontario·Product code KIS·April 12, 2013

    7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code DCF·October 14, 2019

    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code KSG·October 14, 2019

    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

    Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.

    FDA Recall
    Terminated ·Abbott Molecular·Product code MVU·December 22, 2006

    Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 28, 2014

    Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MKW·March 19, 2014

    Flite Clip Slings; patient specific disposable sling; Manufactured in Belgium for Medibo NV, Heikant 5, 3930 Hamont Achel, Belgium; these slings are intended for use with Arjo and BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings. The slings are used to assist with the lifting and transportation of a patient in the horizontal or other required position from one place to another and used only by appropriately trained caregivers.

    FDA Recall
    Terminated ·ArjoHuntleigh·Product code FSA·February 26, 2009

    Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised of 2 x 200 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers; Arjo Inc., 50 N. Gary Avenue, Roselle, IL 60172; Model KS1006

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·October 30, 2006

    Universal SlingBar 350 Product Number: 3156074 Used with the: Viking XS, Viking S, Viking M, Viking L Patient Lifts

    FDA Recall
    Terminated ·Liko AB Alvik·Product code FSA·July 1, 2008

    Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, KMBB4OLU2FUS, KMBB4OSU2FUS, KMBB4PLX2FUS, KMBB4PSX2FUS, KMBB4QLU2FUS, and KMBB4RLX2FUS. The lifter is intended to be used under the direct supervision of trained personnel for the transfer of residents from one location to another.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·September 8, 2008

    Liko Sabina Comfort Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.

    FDA Recall
    Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FSA·January 27, 2011

    Liko Sabina 200 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.

    FDA Recall
    Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FSA·January 27, 2011

    Liko Sabina EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.

    FDA Recall
    Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FSA·January 27, 2011

    Molift Smart 150

    FDA Recall
    Terminated ·Moller Vital Hadelandsvegan 2·Product code FSA·February 15, 2013

    SlingBar 360. Designed to meet the needs for lifting humans.

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code FSA·April 30, 2013

    BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

    FDA Recall
    Terminated ·Prism Medical Services USA·Product code FSA·May 23, 2013

    Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·January 21, 2013