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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 34.

Cincinnati Sub-Zero Products Inc - Cardiopulmonary bypass temperature controllers - Class 2 Recall
ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonary by-pass temperature controllers. The ECMO Heaters are used in conjunction with a heat exchanger to warm the fluid temperature. The device is composed of a heater, a circulating pump, fan, safety high limit, and a microprocessor board. Water is heated and pumped from the unit to the heat exchanger. The device can be set so that the operator can monitor the actual water temperature or, with the use of a 400 series probe, the fluid (external) temperature. This device is intended to provide temperature-controlled warm water flow t...
Source: Medical Device Recalls - May 24, 2012 Category: Medical Equipment Source Type: alerts

Pharmaceutical Innovations, Inc. - OtherSonic Generic Ultrasound Transmission Gel - Class 1 Recall
Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
Source: Medical Device Recalls - May 24, 2012 Category: Medical Equipment Source Type: alerts

Pharmaceutical Innovations, Inc. - OtherSonic Generic Ultrasound Transmission Gel - Class 1 Recall
Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
Source: Medical Device Recalls - May 24, 2012 Category: Medical Equipment Source Type: alerts

College Park Industries, Inc. - Celsus Foot - Class 2 Recall
Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.
Source: Medical Device Recalls - May 23, 2012 Category: Medical Equipment Source Type: alerts

Captiva Spine, Inc - Accessories for the Captiva Spine SmartLOX Cervical Plate System. - Class 2 Recall
Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number 06110041***" "***Part Number CP50160***Single Barrel Fixed Drill Guide***Lot Number 1500707A or Lot Number 06110043***" "***Part Number CP50170***Double Barrel Fixed Drill Guide***Lot Number 1500708A or Lot Number 06110044***" Products are packaged individually and shipped as replacement parts to be placed in the SmartLOX Cervical Plate System tray. The Captiva Spine SmartLOX Cervical Pla...
Source: Medical Device Recalls - May 23, 2012 Category: Medical Equipment Source Type: alerts

Captiva Spine, Inc - Drill Bits for Cervical Plate System - Class 2 Recall
Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
Source: Medical Device Recalls - May 23, 2012 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Linear Accelerator - Class 2 Recall
MLCi/MCLi2. Radiation therapy.
Source: Medical Device Recalls - May 23, 2012 Category: Medical Equipment Source Type: alerts

Computerized Medical Systems Inc - XiO Radiation Treatment Planning System - Class 2 Recall
XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
Source: Medical Device Recalls - May 22, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Ingenuity TF PET/MRI System - Class 2 Recall
Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imagi...
Source: Medical Device Recalls - May 22, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - Access Hybritech Free PSA - Class 3 Recall
Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total PSA levels are between 4 and 10 ng/mL.
Source: Medical Device Recalls - May 22, 2012 Category: Medical Equipment Source Type: alerts

Biosense Webster, Inc. - EZ STEER Catheter - Class 2 Recall
EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation.
Source: Medical Device Recalls - May 22, 2012 Category: Medical Equipment Source Type: alerts

Diamedix Corporation - ENA6 Screen Enzyme Immunoassay Test Kit - Class 2 Recall
Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics, Inc.***Miami, FL 33127 USA-1-800-327-4565***Biohazard***" For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test sys...
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Arcadia Medical Corporation - Tracheostomy tubes - Class 2 Recall
Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access for airway management.
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall
BD FocalPoint"120V LC (Refurbished), Catalog number: 490683. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
Source: Medical Device Recalls - May 21, 2012 Category: Medical Equipment Source Type: alerts

Medical Components, Inc dba MedComp - 8F Plastic Dignity MidSized CT Port - Class 2 Recall
8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician.
Source: Medical Device Recalls - May 18, 2012 Category: Medical Equipment Source Type: alerts

Ethicon Endo-Surgery Inc - The ECHELON 60 Endoscopic Linear Cutter - Class 2 Recall
The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long ECHELON 60 Endoscopic Linear Cutter - Straight are sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. ECHELON 60 instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. Sterile produc...
Source: Medical Device Recalls - May 18, 2012 Category: Medical Equipment Source Type: alerts

MEDDEV USA, INC. - 50 Portal Vein Cannula - Class 2 Recall
50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200 DALLAS, TEXAS 75205 For use in humans. No indication of use is on the label. However, the device can be used for infusion.
Source: Medical Device Recalls - May 17, 2012 Category: Medical Equipment Source Type: alerts

Stryker Howmedica Osteonics Corp. - Triathlon Navigation Tibial Alignment Handle - Class 2 Recall
Tibial Alignment Handle Triathlon Instruments CAT #: 6541-2-807 Nav Tibial Alignment Handle Triathlon Instruments CAT #; 6541-2-808 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The tibial alignment handles Cat# 6451-2-807 and 6541-2-808 are part of the Triathlon Knee Instruments set. The alignment handle is used after the tibial resection portion of a total knee arthroplasty procedure. The alignment handle helps holding and orienting the tibial template and trial, which are used to estimate the size and assess the orientation of the final implant. The implant will provide the new bearing surface of the k...
Source: Medical Device Recalls - May 17, 2012 Category: Medical Equipment Source Type: alerts

Kensey Nash Corp - CollaGuide Collagen Dental Membrane - Class 2 Recall
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 30mm X 40mm REF 20650-03 6280-03 Rev.AE Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in imm...
Source: Medical Device Recalls - May 17, 2012 Category: Medical Equipment Source Type: alerts

Ellman International, Inc. - Pelleve - Class 2 Recall
Pelleve Non-Ablative Wrinkle Treatment Handpiece Pelleve---Elegance through science---Contents: One (1) Pelleve Handpiece (Reusable)---Ellman, 3333 Royal Avenue, Oceanside, NY 11572-3625 USA--- Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.
Source: Medical Device Recalls - May 17, 2012 Category: Medical Equipment Source Type: alerts

Stryker Howmedica Osteonics Corp. - Cutting Edge Acetabular Spherical Reamer - Class 2 Recall
Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. The CuttingEdge acetabular reamers are used to ream the acetabulum and prepare the bone for the insertion of the shell during hip arthroplasty. Surgical procedures for shells used with CuttingEdge instruments indicate that reaming should begin with a Spherical Reamer that is 4mm smaller than the templated or gauged size of the planned shell. Per the procedures, reaming should increase in size by 1mm increments until final sizing is achieved. Surgical judgment is used to assess bone...
Source: Medical Device Recalls - May 17, 2012 Category: Medical Equipment Source Type: alerts

Kensey Nash Corp - CollaGuide Collagen Dental Membrane - Class 2 Recall
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 20mm X 30mm REF 20650-02 6280-02 Rev.AE Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in imm...
Source: Medical Device Recalls - May 17, 2012 Category: Medical Equipment Source Type: alerts

Galil Medical, Inc. - 17G Cryoablation Needle Holder - Class 2 Recall
Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usage: Galil Medical s 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure, and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment, prior to use.
Source: Medical Device Recalls - May 16, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - TrueBeam and TrueBeam STx - Class 2 Recall
TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is indicated. Varian Medical Systems, Palo Alto, CA.
Source: Medical Device Recalls - May 16, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Acuson S1000 - Class 2 Recall
ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system.
Source: Medical Device Recalls - May 16, 2012 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Services L.P. - Coseal Surgical Sealant. - Class 2 Recall
Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.
Source: Medical Device Recalls - May 16, 2012 Category: Medical Equipment Source Type: alerts

Intel-GE Care Innovations LLC - QuietCare - Class 3 Recall
QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Source: Medical Device Recalls - May 16, 2012 Category: Medical Equipment Source Type: alerts

Fresenius Medical Care Holdings, Inc. - Naturalyte Acid Concentrate - Class 2 Recall
Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat. No. 13-2251-0. NaturaLyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Source: Medical Device Recalls - May 15, 2012 Category: Medical Equipment Source Type: alerts

Materialise Dental - NK Flex Pin Guides - Class 2 Recall
PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
Source: Medical Device Recalls - May 14, 2012 Category: Medical Equipment Source Type: alerts

Thera Test Laboratories, Inc. - RF IgA Calibrator - Class 2 Recall
RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA).
Source: Medical Device Recalls - May 14, 2012 Category: Medical Equipment Source Type: alerts

Captiva Spine, Inc - Spinal Intervertebral body Fixation Orthosis - Class 2 Recall
Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be cleaned and sterilized prior to surgery. AORN recommended practices for in hospital sterilization should be followed. Sterilization testing of components has shown the following recommendations for sterilization are effective Method: Steam***Cycle: Pre vacuum***Temperature 270 F (132 C)***Exposure Time: 3 minutes***Contact Information: Captiva Spine Inc. 967 Alternate AA #1 Jupiter, FL 33477. Tel: 877-7...
Source: Medical Device Recalls - May 14, 2012 Category: Medical Equipment Source Type: alerts

Materialise Dental - LPSFlex Pin Guides - Class 2 Recall
PATIENT SPECIFIC INSTRUMENTS LPS-FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID--0242-LF Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
Source: Medical Device Recalls - May 14, 2012 Category: Medical Equipment Source Type: alerts

Materialise USA LLC - NK Flex Pin Guides - Class 2 Recall
PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
Source: Medical Device Recalls - May 14, 2012 Category: Medical Equipment Source Type: alerts

Materialise USA LLC - LPSFlex Pin Guides - Class 2 Recall
PATIENT SPECIFIC INSTRUMENTS LPS-FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID--0242-LF Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
Source: Medical Device Recalls - May 14, 2012 Category: Medical Equipment Source Type: alerts

North Coast Medical Inc - Norco Shoulder Pulley - Class 2 Recall
Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.
Source: Medical Device Recalls - May 14, 2012 Category: Medical Equipment Source Type: alerts