Ethicon, Inc. - Gynecare Thermachoice III - Class 2 Recall
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 7, 2016 Category: Medical Equipment Source Type: alerts
Trental (pentoxifylline) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
DRUG INTERACTIONS
Bleeding has been reported in patients treated with Trental with or without concomitant... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Boston Scientific Corporation - Chariot Guiding Sheath - Class 1 Recall
Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110 Guiding Sheath 6F, 45 cm, ST, TB H74939277645120 Guiding Sheath 6F, 45 cm, MP, CC H74939277645210 Guiding Sheath 6F, 45 cm, MP, TB H74939277645220 Guiding Sheath 6F, 65 cm, ST, CC H74939277665110 Guiding Sheath 6F, 65 cm, ST, TB H74939277665120 Guiding Sheath 6F, 90 cm, ST, CC H74939277690110 Guiding Sheath 6F, 90 cm, ST, TB H74939277690120 G...
Source: Medical Device Recalls - December 19, 2015 Category: Medical Equipment Source Type: alerts
Ethicon Endo-Surgery Inc - HARMONIC ACE 7 Laparoscopic Shears - Class 2 Recall
HARMONIC ACE¿+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2015 Category: Medical Equipment Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Maquet Universal Frame for Positioning Patients - Class 2 Recall
Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the vertical position with regard to the spine and the large blood vessels there. This positioning method is thus suitable for intervention...
Source: Medical Device Recalls - November 10, 2015 Category: Medical Equipment Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Maquet Adjustable Positioning Elements - Class 2 Recall
Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the vertical position with regard to the spine and the large blood vessels there. This positioning method is thus suitable fo...
Source: Medical Device Recalls - November 10, 2015 Category: Medical Equipment Source Type: alerts
Aggrenox (aspirin/extended release dipyridamole) Capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2015
WARNINGS AND PRECAUTIONS
Risk of Bleeding
Risk factors for bleeding include the use of other drugs that increase... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - November 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Clinical Innovations, LLC - The EBB Complete Tamponade System - Class 2 Recall
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 16, 2015 Category: Medical Equipment Source Type: alerts
ITC-Nexus Dx - Surgicutt Bleeding Time Device - Class 2 Recall
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Coreva Health Science LLC - ActCel Topical Hemostatic Dressing - Class 2 Recall
ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room temperature (41F-104F). Do not autoclave. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 31, 2015 Category: Medical Equipment Source Type: alerts
Orthovita, Inc., dBA Stryker Orthobiologics. - Vitagel - Class 2 Recall
Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) 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 - March 31, 2015 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - da Vinci Harmonic ACE - Class 2 Recall
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2015 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - da Vinci Harmonic ACE - Class 2 Recall
HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2015 Category: Medical Equipment Source Type: alerts
Synthes, Inc. - Hemostatic Bone Putty - Class 2 Recall
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2015 Category: Medical Equipment Source Type: alerts
Enhancement Medical, LLC - Enhancement Medical expression - Class 1 Recall
Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 9, 2014 Category: Medical Equipment Source Type: alerts
