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 3.

GE Healthcare, LLC - Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories. - Class 2 Recall
Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories. The intended use of the system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.
Source: Medical Device Recalls - February 13, 2013 Category: Medical Equipment Source Type: alerts

Mizuho OSI - Mizuho Orthopedic Systems, Inc. - Class 2 Recall
Manufactured by Mizuho Orthopedic Systems, Inc. The table is designed to safely hold in proper position a patient undergoing orthopedic surgical procedures including supine position for Hip Pining, IM Nailing of the Femur or Tibia and Hip Pinning and Lateral Decubitus position for IM Nailing of the femur. It is capable of pulling both Skin and Skeletal traction.
Source: Medical Device Recalls - February 13, 2013 Category: Medical Equipment Source Type: alerts

Remel Inc - Remel X/pect Clostridium Difficile Toxin A/B (40 tests) - Class 2 Recall
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.
Source: Medical Device Recalls - February 12, 2013 Category: Medical Equipment Source Type: alerts

Remel Inc - Remel X/pect Clostridium Difficile Toxin A/B (20 tests) - Class 2 Recall
Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.
Source: Medical Device Recalls - February 12, 2013 Category: Medical Equipment Source Type: alerts

Breg Inc, An Orthofix Company - BREG Sterile Polar Pads - Class 2 Recall
BREG Sterile Polar Pads, Breg, Inc., 2885 Loker Ave, E., Carlsbad, CA 92010; 02356 Rev M, PAD M/U XL STER, Assembled in Mexico, QTY 1, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410. Local anesthetic effect.
Source: Medical Device Recalls - February 12, 2013 Category: Medical Equipment Source Type: alerts

Breg Inc, An Orthofix Company - BREG Cold Therapy Combination Units - Class 2 Recall
BREG Cold Therapy Combination Units containing Sterile Polar Pads. Breg, Inc., 2885 Loker Ave, E., Carlsbad, CA 92010; 02356 Rev M, PAD M/U XL STER, Assembled in Mexico, Box 24, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.
Source: Medical Device Recalls - February 12, 2013 Category: Medical Equipment Source Type: alerts

Aesculap, Inc. - Aesculap(R) Miethke Shunt System - Class 2 Recall
Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet &amp;amp;amp;amp;amp;amp; RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Source: Medical Device Recalls - February 12, 2013 Category: Medical Equipment Source Type: alerts

Remel Inc - Oxoid Antimicrobial Susceptibility Discs FOX30, Cefoxitin - Class 2 Recall
Oxoid, Antimicrobial Susceptibility Discs, Cefoxitin, 30ug, REF CT0119B Product Usage: An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Cefoxitin).
Source: Medical Device Recalls - February 12, 2013 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - CDI 101 Hematocrit/Oxygen Saturation Monitoring System - Class 2 Recall
CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors the blood/oxygen saturation, hematocrit and hemoglobin levels.
Source: Medical Device Recalls - February 12, 2013 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - DPM Central Monitoring System - Class 2 Recall
DPM Central Monitoring System with ambulatory Telepack Mindray DS USA, Inc. 800 MacArthur Blvd., Mahwah, NJ 07430. The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
Source: Medical Device Recalls - February 11, 2013 Category: Medical Equipment Source Type: alerts

Bacterin International, Inc. - Osteoselect Demineralized Bone Matrix DMB Putty - Class 2 Recall
Osteoselect Demineralized Bone Matrix DMB Putty labeled in part: "Processed By: BACTERIN INTERNATIONAL, INC. Bacterin international, Inc. 600 Cruiser Lane Belgrade, MT 59714 Phone: 888-886-9354 Fax: 406-388-0422 www.bacterin.com Graft ID# B090056-664 Donor# B090056 Description: OsteoSelect DBM Putty 2.5cc Dimensions: ONE (1) PACKAGE - CONTAINING 2.5cc Expiration Date: 12/25/2011***LBL 210-0010-1 REV: 040109" Additionally, contained in an outlined box is the following: "STERILE R" The additional recalled device has the same labeling with the only difference being the Graft ID#: "B090056-675" B...
Source: Medical Device Recalls - February 11, 2013 Category: Medical Equipment Source Type: alerts

St Jude Medical Inc - AMPLATZER TorqVue FX Delivery System - Class 1 Recall
AMPLATZER¿ TorqVue¿ FX Delivery System, Rx Only, Sterilized using ethylene oxide, AGA Medical corporation, 5050 Nathan Lane North, Plymouth, MN 55442. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Used to close atrial septal defects between the right and left atriums.
Source: Medical Device Recalls - February 11, 2013 Category: Medical Equipment Source Type: alerts

Fresenius Medical Care Holdings, Inc. - Fresenius Liberty Cycler Set Single Conn. Ext. DL. - Class 2 Recall
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
Source: Medical Device Recalls - February 11, 2013 Category: Medical Equipment Source Type: alerts

Remel Inc - Legionella BCYE Growth Supplement SR0110C - Class 2 Recall
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCVE Medium used for isolation of Legionellae from clinical and environmental samples.
Source: Medical Device Recalls - February 11, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Giraffe and Panda Warmer TPiece Resuscitation System - Class 1 Recall
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
Source: Medical Device Recalls - February 8, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Giraffe and Panda Bag and Mask Resuscitation System - Class 1 Recall
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
Source: Medical Device Recalls - February 8, 2013 Category: Medical Equipment Source Type: alerts

Allergen Medical - Allergan SeriScaffold Surgical Scaffold - Class 2 Recall
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Source: Medical Device Recalls - February 7, 2013 Category: Medical Equipment Source Type: alerts

Custom Healthcare Systems, Inc. - Breast Biopsy tray - Class 2 Recall
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Source: Medical Device Recalls - February 7, 2013 Category: Medical Equipment Source Type: alerts

Custom Healthcare Systems, Inc. - Breast Biopsy Kit - Class 2 Recall
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Source: Medical Device Recalls - February 7, 2013 Category: Medical Equipment Source Type: alerts

Hitachi Chemical Diagnostics Inc - OPTIGEN Food 30 - Class 3 Recall
OPTIGEN Food 30; Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France Allergen testing
Source: Medical Device Recalls - February 7, 2013 Category: Medical Equipment Source Type: alerts

Medacta Usa Inc - Quadra Trial Broach size 0 - Class 2 Recall
The Quadra Trial Broach size 0 Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
Source: Medical Device Recalls - February 7, 2013 Category: Medical Equipment Source Type: alerts

Diagnostic Hybrids Inc - Diagnostic Hybrids Inc. - Class 3 Recall
Diagnostic Hybrids, Inc., 1055 East State Street, Suite 100, Athens, OH 45701. Primary monkey kidney tissue cultures are intended to be used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens. Primary monkey kidney tissue cultures are used to amplify viruses to a detectable level from patient specimens that are sent by physicians for the purpose of identifying a stated virus or virus group.
Source: Medical Device Recalls - February 7, 2013 Category: Medical Equipment Source Type: alerts

Remel Inc - Oxoid Antimicrobial Susceptibility Test Discs - Class 2 Recall
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel &amp;amp;amp;amp; Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam).
Source: Medical Device Recalls - February 6, 2013 Category: Medical Equipment Source Type: alerts

Linvatec Corp. dba ConMed Linvatec - PopLok Punch 3.5MM - Class 2 Recall
PopLok Punch labeled in part: ***PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA*** Orthopedic manual surgical instrument - Bone Punch
Source: Medical Device Recalls - February 5, 2013 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - Novation Crown Cup Connection GXL Neutral Liners - Class 2 Recall
***NOVATION CROWN CUP***NEUTRAL LINER***Use with Crown Cup Only***GXL UHMWPE***SN 0123456***REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Source: Medical Device Recalls - February 5, 2013 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - NOVATION CROWN CUP 5mm LATERALIZED LINER - Class 2 Recall
***NOVATION CROWN CUP***+5mm LATERALIZED LINER***Use with Crown Cup Only***GXL UHMWPE***SN 0123456***REF 136-32-53***. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Source: Medical Device Recalls - February 5, 2013 Category: Medical Equipment Source Type: alerts

Synthes USA HQ, Inc. - Synthes(R) Spine Vectra, VectraT and VectraOne Anterior Cervical Plating 2.5mm Drill Bit - Class 2 Recall
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

The Anspach Effort, Inc. - Bearing Sleeve with Removable Bur Guard - Class 2 Recall
The custom device is a reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Trilogy Acetabular Shell Spiked - Class 2 Recall
Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Lansinoh Laboratories Inc - THERA PEARL 3in1 BREAST THERAPY - Class 2 Recall
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Trilogy F/M Acetabular Shell without holes - Class 2 Recall
Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Trilogy F/M Acetabular Shell with UniHole - Class 2 Recall
Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Trilogy Acetabular Shells with Holes - Class 2 Recall
Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Trilogy Acetabular AB Shells with Holes - Class 2 Recall
Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Synthes USA HQ, Inc. - Synthes(R) Spine Vectra, VectraT and VectraOne Adjustable Drill Stop - Class 2 Recall
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Trilogy F/M Acetabular Shell without holes - Class 2 Recall
Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Trilogy Acetabular AB Shells with Cluster Holes - Class 2 Recall
Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Trilogy Acetabular Shell with Cluster Holes - Class 2 Recall
Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Invacare Corporation - Solara 3G Custom Manual Wheelchair - Class 2 Recall
Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Winco Mfg., LLC - Cozy Comfort Premier Recliner 5580 - Class 2 Recall
Cozy Comfort Premier Recliner 5580 The products are a multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Winco Mfg., LLC - PREMIER LIFECARE RECLINER 5400 - Class 2 Recall
PREMIER LIFECARE RECLINER 5400 The products are a multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Winco Mfg., LLC - PREMIER CARE RECLINER 5570/5574 - Class 2 Recall
PREMIER CARE RECLINER 5570/5574 The products are a multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Winco Mfg., LLC - Designer Care Cliner 6700/6704/6710 - Class 2 Recall
Designer Care Cliner 6700/6704/6710 The products are a multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Oxus America, Inc. - Reliability Plus by Drive - Class 2 Recall
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
Source: Medical Device Recalls - February 2, 2013 Category: Medical Equipment Source Type: alerts

Ormco/Sybronendo - Lightspeed LSX Files - Class 2 Recall
Sybron Endo Lightspeed LSX Files Intended to be an engine-driven rotary endodontic instruments used during endodontic procedures for cleaning and shaping the root canal.
Source: Medical Device Recalls - February 1, 2013 Category: Medical Equipment Source Type: alerts

Tobii Assistive Technology, Inc. - P10 Tobii battery pack - Class 2 Recall
P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device
Source: Medical Device Recalls - February 1, 2013 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Phillips Easy Diagnost Elva DRF - Class 2 Recall
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
Source: Medical Device Recalls - February 1, 2013 Category: Medical Equipment Source Type: alerts

Hamilton Medical Inc - The HAMILTON T1 - Class 1 Recall
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Source: Medical Device Recalls - January 31, 2013 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - White Acetal Titanium Rectal Retractor - Class 2 Recall
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Source: Medical Device Recalls - January 31, 2013 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - Rectal Retractor - Class 2 Recall
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Source: Medical Device Recalls - January 31, 2013 Category: Medical Equipment Source Type: alerts