Medical Equipment Alerts This is an OPML file. It can be used to export all the MedWorm RSS feeds on this topic into your personal RSS reader (usually you have to save this file to your own computer before clicking on an Import OPML command in your own feed reader to upload the file which will then import all the feeds) or it can be used by webmasters to integrate MedWorm feeds with their own website. This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog. Subscribe to this data using MyMedWorm.Subscribe to this data using GoogleReader.Subscribe to this data using Bloglines.Subscribe to this data using MyYahoo.

This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 4.

Philips Healthcare Inc. - Juno - Class 2 Recall
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
Source: Medical Device Recalls - January 28, 2013 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - Mindray DS USA Inc. - Class 2 Recall
DPM5 Monitor Product Usage: A vital signs monitor used on human patients. The target populations are adult, pediatric, and neonatal patients. The DPM5 Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and intuitive menu system. The patient parameters that can be monitored by DPM5 monitors are ECG (3- lead or 5-lead selectable), Heart Rate (HR), Pulse Rate(PR), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP) , Saturation of Pulse Oxygen (SpO2), Temperature (TEMP), Invasive Blood Pressure (IBP), Carbon Dioxide (CO), Anesthetic Gases (AG) . Its design allows the oper...
Source: Medical Device Recalls - January 27, 2013 Category: Medical Equipment Source Type: alerts

Becton Dickinson & Co. - BBL(TM) Fildes Enrichment - Class 2 Recall
BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms, including the X (hemin) and V (n...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

bioMerieux, Inc. - BacT/ALERT SA Blood Culture Bottle - Class 2 Recall
BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

Cordis Corporation - Cordis ExoSeal Vascular Closure Device - Class 2 Recall
Cordis***a Johnson &amp;amp;amp;amp;amp; Johnson Company***Cordis***ExoSeal(TM)***6F***Vascular Closure Device***REF cat. No EX600***LOT No. LOTNR***Use by UBD***STERILE R***Sterilized with Irradiation *** Attention, see Instructions for Use.***DO NOT RESTERILIZE***For one use only.***Do not use open or damaged packages.***Store in a cool, dark, dry place. ***Nonpyrogenic***LBEX6001.4***JOBNR***Assembled in Mexico***Cordis***Cordis ExoSeal (TM) EX600***6F***LOT***LOTNR***+H739EX60023***SEC.BARCODE***Cordis Corporation***14201 North West 60th Avenue***Miami Lakes, Florida 33014***USA. The Cordis ExoSeal (TM) VCD is...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

Medisystems a NX Stage Company - Buttonhole Needle Set - Class 2 Recall
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

Medisystems a NX Stage Company - Medisytems - Class 2 Recall
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation - Class 2 Recall
UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it h...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - Electrosurgical Tip Cleaner - Class 2 Recall
Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION 525 French Road, Utica, NY 13502-5944 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092281. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. T...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - ELECTROSURGICAL ENT NEEDLE ELECTRODE - Class 2 Recall
ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092258. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - UltraClean(R) Accessory Electrode - Class 2 Recall
UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, UTICA, NY 13502 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Single U...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - ELECTROLASE(R) HYFRECATOR(R) ELECTRODES SHARP - Class 2 Recall
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092250. The Electrolase¿ Sterile Disposable Electrodes are intended to be used as active RF electrodes for desiccation, fulguration and coagulation. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, - Class 2 Recall
Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick&...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - ELECTROLASE(R) HYFRECATOR(R) ELECTRODES BLUNT - Class 2 Recall
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL 092250. The Electrolase¿ Sterile Disposable Electrodes are intended to be used as active RF electrodes for desiccation, fulguration and coagulation. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician ...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, - Class 2 Recall
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -- CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - UltraClean(R) Accessory Electrode 4 inch Coated Blade - Class 2 Recall
UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick"...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, - Class 2 Recall
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick&q...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation - Class 2 Recall
UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5944 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as i...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - UltraClean(R) Accessory Electrode 6 inch Coated Blade - Class 2 Recall
UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION, 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick"...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - TUR/Endoscopic Cable - Class 2 Recall
TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092258. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick" finish. The Si...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation - Class 2 Recall
UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - CONMED(R) ELECTROSURGICAL SAFETY HOLSTER - Class 2 Recall
CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092249. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick"...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation - Class 2 Recall
UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as i...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - UltraClean(R) Accessory Electrode 1 inch Coated Needle - Class 2 Recall
UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a "non-stick"...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation - Class 2 Recall
Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as ...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - ABC(R) NOZZLE - Class 2 Recall
ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL E323246. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has ...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

ConMed Corporation - UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation - Class 2 Recall
UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

Ansell Healthcare Products LLC - LifeStyles Pleasure Collection Condoms - Class 2 Recall
LifeStyles Pleasure Collection 30 Premium Lubricated Condoms UPC 0-70907-02625-0. A sheath which covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

Abbott Point of Care Canada Limited - Abbott Point of Care iStat cTnI cartridge - Class 2 Recall
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confir...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conf...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conf...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts

Abbott Laboratories - ARCHITECT 25OH Vitamin D Reagent Kit - Class 2 Recall
ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA, Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany, product of Spain; Product Usage:The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.
Source: Medical Device Recalls - January 23, 2013 Category: Medical Equipment Source Type: alerts

Becton Dickinson & Co. - BD MAX (tm) (6 channel) Instruments - Class 2 Recall
BD MAX (tm) (6 channel) Instruments, Catalog number 441916, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA*** The BD MAX" System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial and research settings. The MAX reader assembly is the optics component of the instrument that translates PCR amplification into curves. The cu...
Source: Medical Device Recalls - January 22, 2013 Category: Medical Equipment Source Type: alerts

AMS Innovative Center - San Jose - GreenLight HPS (High Performance System); GreenLight XPS ( Xcelerated Performance System) - Class 2 Recall
GreenLight HPS (High Performance System) GreenLight XPS ( Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center - Silicon Valley, 3070 Orchard Drive, San Jose, CA 95134. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasis. The entire laser unit and controls are contained in a single console that is connected to external electricity and are required to meet IEC 60601.
Source: Medical Device Recalls - January 22, 2013 Category: Medical Equipment Source Type: alerts

Becton Dickinson & Co. - BBL Crystal Enteric/Nonfermenter ID Kit - Class 2 Recall
BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, labeled in part ***Becton, Dickinson and Company, Sparks MD 21152*** The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
Source: Medical Device Recalls - January 20, 2013 Category: Medical Equipment Source Type: alerts

IDS (Immunodiagnostic Systems Ltd.) - Class 2 Recall
25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.
Source: Medical Device Recalls - January 18, 2013 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - Roche COBAS INTEGRA 400 and 400 plus Analyzer - Class 3 Recall
Roche COBAS INTEGRA 400 and 400 plus Analyzer The Roche COBAS INTEGRA 400/400 plus Analyzer is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Source: Medical Device Recalls - January 18, 2013 Category: Medical Equipment Source Type: alerts

Vycor Medical, Inc. - Vycor Medical ViewSite Brain Access System - Class 1 Recall
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts

Stryker Howmedica Osteonics Corp. - Hoffman LRF Wire Bolt - Class 2 Recall
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts

Bausch and Lomb, Incorporated - Bausch & Lomb Disposable 27G cannula - Class 1 Recall
Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts

Spacelabs Healthcare, Llc - Spacelabs Smart Disclosure System, Model 92810 - Class 2 Recall
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, includin...
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts

Quanta System, S.p.A. - Eterna Giovinezza System - Class 2 Recall
Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts

Quanta System, S.p.A. - Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser - Class 2 Recall
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or perma...
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts