GASTRO-COTE (Bismuth Subsalicylate) Suspension [Henry Schein Animal Health]
Updated Date: Sep 15, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 15, 2016 Category: Drugs & Pharmacology Source Type: alerts
MD GASTROVIEW (Diatrizoate Meglumine And Diatrizoate Sodium) Solution [Liebel-Flarsheim Company LLC]
Updated Date: Aug 29, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 29, 2016 Category: Drugs & Pharmacology Source Type: alerts
GASTROGARD (Omeprazole) Paste [Merial, Inc.]
Updated Date: Aug 23, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 23, 2016 Category: Drugs & Pharmacology Source Type: alerts
Intuitive Surgical, Inc. - CURVEDTIP STAPLER 30,IS4000, model number 470530 - Class 2 Recall
CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2016 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - STAPLER 45, IS4000, model number 470298 - Class 2 Recall
STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2016 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - STAPLER 30, IS4000, model number 470430 - Class 2 Recall
STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2016 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Class 2 Recall
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2016 Category: Medical Equipment Source Type: alerts
Custom Ultrasonics, Inc. - System 83 Plus 2 Endoscope/Washer/Disinfector - Class 2 Recall
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 7, 2016 Category: Medical Equipment Source Type: alerts
Covidien, LLC - Cytosponge Cell Collection Device - Class 2 Recall
Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 6, 2016 Category: Medical Equipment Source Type: alerts
Covidien, LLC - Cytosponge Cell Collection Device - Class 2 Recall
Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 6, 2016 Category: Medical Equipment Source Type: alerts
