Teleflex Medical - Sengstaken Tube and SengstakenBlakemore Tube - Class 2 Recall
Sengstaken Tube and Sengstaken-Blakemore Tube. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 25, 2014 Category: Medical Equipment Source Type: alerts
Hologic, Inc - NovaSure Radiofrequency Control Units - Class 2 Recall
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2014 Category: Medical Equipment Source Type: alerts
Teleflex Medical - Weck Electrosurgical Coagulation Suction Tube 8 - Class 2 Recall
Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by use of high-frequency electrical current. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 16, 2014 Category: Medical Equipment Source Type: alerts
Teleflex Medical - Weck Electrosurgical Coagulation Suction Tube 6 - Class 2 Recall
Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by use of high-frequency electrical current. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 16, 2014 Category: Medical Equipment Source Type: alerts
Karl Storz Endoscopy America Inc - Broncho Flexible Fiberscope - Class 2 Recall
Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 18, 2013 Category: Medical Equipment Source Type: alerts
Maquet Cardiovascular, LLC - Vasoview Hemopro Endoscopic Vessel Harvesting System - Class 2 Recall
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. ...
Source: Medical Device Recalls - December 7, 2013 Category: Medical Equipment Source Type: alerts
Assuramed - Hemoccult II SENSA elite - Class 2 Recall
Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a ...
Source: Medical Device Recalls - September 14, 2013 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corporation - Helistat Absorbable Hemostatic,Collagen Based - Class 2 Recall
Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2013 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corporation - CollaTape Absorbable Collagen Wound Dressing for Dental Surgery - Class 2 Recall
Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2013 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corporation - CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery - Class 2 Recall
CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2013 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corporation - Helitene Absorbable Collagen Hemostatic Sponge - Class 2 Recall
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2013 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corporation - CollaCote Absorbable Collagen Wound Dressing for Dental Surgery - Class 2 Recall
CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2013 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corporation - HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery - Class 2 Recall
HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2013 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corporation - INSTAT - Class 2 Recall
INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2013 Category: Medical Equipment Source Type: alerts
Integra LifeSciences Corporation - OraPlug Absorbable Collagen Wound Dressing for Dental Surgery - Class 2 Recall
Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2013 Category: Medical Equipment Source Type: alerts
