46 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bravo pH Monitoring System Receiver
FDA Recall
Terminated
·Medtronic Gastroenterology Urology·Product code FGM·February 6, 2004
Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Enforcement
Class II
·Terminated·Viterion TeleHealthcare Llc·February 20, 2013
Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Recall
Terminated
·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012
Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect, accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and the practitioner. The physiological monitoring instrument, selected by the healthcare practitioner, operates in conjunction with the Patient Terminal located in the patients home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system, and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather, the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor.
FDA Recall
Terminated
·Viterion TeleHealthcare Llc·Product code MWI·May 25, 2011
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
FDA Enforcement
Class II
·Terminated·SA3, LLC·April 13, 2022
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
FDA Recall
Terminated
·SA3, LLC·Product code OLR·February 21, 2022
Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Enforcement
Class II
·Terminated·Viterion TeleHealthcare Llc·February 20, 2013
Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Recall
Terminated
·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012
Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Recall
Terminated
·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012
BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips), 322003 (100 count BD Test strips), and 322009 (10 count BD Test strips). Health Hazard Evaluation: There is negligible medical risk to patients with diabetes using the BD blood glucose systems due to the increase of E-3 error messages.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code NBW·January 29, 2004
Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
FDA Enforcement
Class II
·Terminated·Viterion TeleHealthcare Llc·February 20, 2013
Case Label: McKesson Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-104 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc 1 - Thumb Control Ring Piston Syringe (Catheter Tip), 60 cc 1- Graduated Solution Container, 500 cc, 1 - Underpad, 1-Sterile Alcohol Prep Pad Reorder No. 37-104 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Intended use: The trays are irrigation trays for catheters
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Universal drainage kit, catalog# 900-032
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code FCM·December 8, 2011
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 12KPES SIZE: 12Fr Product No: AAM 8012KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 12KPES Product No: AAM 8012KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011
Case Label: REORDER NO. 6112 STERILE WELCON BRAND 60cc PISTON SYRINGE With Sterile Water 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 6112 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6009, R1 WELCON BRAND SINGLE USE Thumb Control Ring Piston Syringe With 100 mL Sterile Water 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: 1200 mL Graduated Drain Tray 100 mL Sterile Water 60cc Thumb Control Ring Syringe Tip Protector Antiseptic Wipe Waterproof Underpad Intended use: The trays are irrigation trays for catheters
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: REORDER NO. 7502 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber Catheter includes BZK Swabsticks Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7502 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Disposable Urethral Catheterization Tray With 14 French Red Rubber Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: 1200 mL Graduated Drain Tray 14 French Red Rubber Catheter Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: REF UT8155 Urethal Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Tray Label: Cysto-Care Coloplast REF: UT8155 Urethral Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr red rubber latex catheter Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: REF UT8150 Urethral Insertion Tray 14 Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Tray Label: Cysto-Care Coloplast REF: UT8150 Urethral Insertion Tray 14 Fr Red Rubber Catheter with PVP Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr red rubber latex catheter Swabsticks (3) PVP solution For Rx Only Sterile unless package is damaged or opened. Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: UT8140 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark Tray Label: Cysto-Care Coloplast REF: UT8140 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with PVP Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr. PVC Nelaton catheter Swabsticks (3) PVP solution For Rx only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: REORDER NO. 6101 STERILE WELCON BRAND Standard Irrigation Tray Clear-Vu Bulb Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Product Label: REORDER NO. 6101 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6031, R1 WELCON BRAND SINGLE USE Standard Irrigation Tray With Clear-Vu Bulb Syringe 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFree CONTENTS: 1200 mL Graduated Drain Tray 500 mL Graduate Bulb Syringe Waterproof Underpad Prep Pad Protective Cap Intended use: The trays are irrigation trays for catheters
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011