Healthtronics, Inc. - HealthTronics Endocare 3.8mm RenalCryo Cryoprobe - Class 2 Recall
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HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L, Endocare, Inc., a wholly owned subsidiary of HealthTronics, Inc., 9825 Spectrum Dr. Building 3, Austin, TX 78717 The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System. The CryoCare Surgical System is intended for use in surgical procedures in the arrears of general surgery, dermatology, neurology, thoracic surgery, pulmonary surgery, (Source: Medical Device Recalls)
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Quanta System, S.p.A. - Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser - Class 2 Recall
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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 permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrop...
Galil Medical, Inc. - VisualICE Cryoablation System - Class 2 Recall
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Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures. (Source: Medical Device Recalls)
Cardinal Health - Presource Custom Sterile Surgical and Procedure Kits - Class 2 Recall
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Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components: a) Jobri Circumcision Strap, Small, 2 x 8 inch, component part number 086-0001; b) Jobri Circumcision Strap, Large, 2 x 10 inch, component part number 086-0002; The restraint is used to secure an infant during a circumcision procedure. Product Usage: The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant...
Teleflex Medical - DermaHood Neuro Elastic Retractors - Class 2 Recall
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Weck, DermaHook ¿ (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. (Source: Medical Device Recalls)
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Teleflex Medical - DuraHook Neuro Elastic Retractors - Class 2 Recall
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Weck, DuraHook ¿ (6mm) and ¿ (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. (Source: Medical Device Recalls)
Cardinal Health - Presource Custom Sterile Surgical and Procedure Kits - Class 2 Recall
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Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: a) 24" Infant Tape Measure, component 30942P; b) Silicone Tubing, component SFM3-4450; c) Triple Dye Drug, 10 unit dose, component PM1022; d) Assembly Swabstick, component PS004; e) 18x26 Poly Lined Towel, component 8580Z; f) Disposable Vein Stripper, component 63-0431; g) Cotton Glove, Large, White, PR, NS, component 1051; h) Cotton Glove, Medium, White, PR, NS, component 1051M; i) 6 Inch Metric-Inch Ruler, compon...
Applied Medical Resources Corp - Surgical Clamp Inserts - Class 2 Recall
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Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws. (Source: Medical Device Recalls)
Integra Limited - Integra CUSA Selector NXT Ultrasonic Surgical Aspirator - Class 2 Recall
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Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. including Neurosurgery. Gastrointestinal and affiliated organ surgery. Urological surgery. Plastic and Reconstructive surgery. General surgery, Orthopedic surgery. Gynecological surgery, Thoracic surgery. laparoscopic surgery and Thoracoscopic surgery. (Source: Medical Device Recalls)
Galil Medical, Inc. - SeedNet Cryosurgiclal system - Class 2 Recall
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SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not approved in the US: CryoHit MRI Cryoblation System, model FPRCH2048. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient;s target organ. The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The modified SeedNet is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urol...
Galil Medical, Inc. - Presice Cryosurgiclal system - Class 2 Recall
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Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in the US: CryoHit-P Cryoblation System, model FPRCH2058. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient;s target organ. Presice is intended for cryogenic destruction of tissue during surgical procedures. Presice is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to...
Smith & Nephew, Inc. Endoscopy Division - Smith & Nephew Aimer Endofemoral - Class 2 Recall
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Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. (Source: Medical Device Recalls)
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Smith & Nephew, Inc. Endoscopy Division - Class 2 Recall
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Smith & Nephew Aimer Endofemoral 4mm Offset (Red) Catalog Number: 72201715F (Refurbished) ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. (Source: Medical Device Recalls)
Smith & Nephew, Inc. Endoscopy Division - Smith & Nephew Aimer Endofemoral - Class 2 Recall
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Smith & Nephew Aimer Endofemoral 4mm Offset (Purple) Catalog Number: 72201714F (Refurbished) ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. (Source: Medical Device Recalls)
Smith & Nephew, Inc. Endoscopy Division - Smith & NephewAimer Endofemoral - Class 2 Recall
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Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. (Source: Medical Device Recalls)
Smith & Nephew, Inc. Endoscopy Division - Smith & Nephew Aimer Endofemoral - Class 2 Recall
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Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. (Source: Medical Device Recalls)
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Medtronic Sofamor Danek Usa, Inc - Dallas Distribution - Medtronic Midas Rex Legend Footed Attachment - Class 2 Recall
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Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications. (Source: Medical Device Recalls since July 07, 2006)
Stryker Communications Corp - Surgical Table Headrest - Class 2 Recall
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Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by Stryker Communications, Flower Mound, TX 75028. The Vertier surgical table is intended for use in general surgery or diagnostic examinations to position a patient. The Vertier Surgical Table is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. The headrest is included with each table. (Source: Medical Device Recalls since July 07, 2006)
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FDA Okays Sealant for General Surgical Bleeding Control
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ROCKVILLE, Md. -- The FDA announced today it has expanded the indication for Evicel, a liquid fibrin sealant, to include all of general surgery. (Source: MedPage Today Product Alert)
Cardinal Health - Presource Custom Sterile Packs - Class 2 Recall
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Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom sterile packs were packaged with the bulk, non-sterile drapes and then the complete custom pack was sterilized; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: a) SVC13AMEMK - Sterile Open Heart Adult Pk; b) SCV31OHMPJ - Sterile Open Heart w Drapes Pk; c) SVC42OPVCG - Sterile Open Heart Adult Pack; d) SCV32CPMUO - Sterile CAB 146060 Pack; e) SCV34OHTMJ - Sterile Basin Pack; f) SCV31LVLUM - Sterile Liver Transplant Pack; g) SCV19CVHHF - Sterile Cardiovascular Pack; h) SCV11ADLLD - Sterile Open Heart/Adult; i) SCV92CBHRB - Sterile CABG Pack; j) SCV92CASIA - Sterile Cardiovascular Pack; k) SBA32GSMUL - Sterile General Surgery Pac...
Cardinal Health - Cardinal Health Sterile Presource PBDS Modules - Class 2 Recall
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Cardinal Health Sterile Presource PBDS Modules, have Presource Custom Sterile Packs containing the Cardiovascular Split Drape II or a Sterile Convertors Tiburon Cardiovascular Split Drape II bundled in the module; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: PBDS modules containing catalog 9158: a) PC40OHRJR - Basic Open Heart Kit, RWJ; b) PC40OHRJT - Basic Open Heart Kit, RWJ; PBDS modules containing custom sterile packs: a) PWOCBSBSE - Breast Reduction Kit, pack SBA13BRBSE; b) PC40CGSLK - CABG Kit, St Lukes, pack SCV11CESLB; c) PCOCCGNYO - CABG Kit, New York Queens, pack SCV11OCNYN; d) PCOCOHNME - Open Heart Kit, pack SCV11OHNMC; e) PC40VPSLD - Valve Kit, pack SCV11VASLB; f) PC78OHUVZ - Open Heart Kit, Utah ...
Candela Laser Corporation - Class 2 Recall
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Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300 (Source: Medical Device Recalls since July 07, 2006)