53 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. The device is used as a General Purpose Aspiration and Injection Needle.
FDA Recall
Terminated
·Remington Medical Inc.·Product code GDM·April 6, 2009
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
FDA Recall
Terminated
·Getinge (Suzhou) Co Ltd NO 158 Fangzhoulu Zhong Xin Gongyeyuanqu Suzhou City China·Product code FNM·April 15, 2021
Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing alternating pressure therapy and lateral rotation up to 45 degrees side to side.
FDA Recall
Terminated
·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008
Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
FDA Recall
Terminated
·American National Mfg Inc·Product code FNM·July 11, 2016
Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.
FDA Recall
Terminated
·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008
AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glendale, CA. The device is intended to treat or prevent decubitus ulcers, extensive burns, urinary tract blockage and to aid circulation.
FDA Recall
Terminated
·Encompass Therapeutic Support Systems dba BG North America·Product code FNM·March 5, 2010
Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle.
FDA Recall
Terminated
·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008
Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing pulsation therapy.
FDA Recall
Terminated
·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code FNM·March 18, 2014
Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the distribution of body weight for pressure relief. PositionPRO offers turn assist. PositionPRO is for use with GoBed II, Secure II/3, InTouch, and Epic II 84 in. x 35 in. flat deck frames. This surface is powered via an AC power cord that comes in either a 4 foot long option (PN QDF8087) or 15 foot long option (PN QDF8088). The 4 foot long option is used when the surface is plugged into the auxiliary outlet of the bed. The 15 foot long option is utilized when the surface needs to be plugged into a wall outlet. This product uses a power cord, manufactured by ElectriCord that plugs into the wall outlet or the auxiliary outlet of the bed that the surface is placed onto.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FNM·December 3, 2015
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
FDA Enforcement
Class II
·Terminated·Atlas Spine, Inc.·May 18, 2016
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
FDA Recall
Terminated
·Atlas Spine, Inc.·Product code MQP·July 26, 2013
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.
FDA Recall
Terminated
·Abbott Laboratories·Product code JJX·April 30, 2014
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.
FDA Enforcement
Class II
·Terminated·Abbott Laboratories·November 5, 2014
Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.
FDA Recall
Terminated
·Mermaid Medical A/S Frydensbergvej 25 Stenl?se Denmark·Product code DWO·June 15, 2015
Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.
FDA Enforcement
Class II
·Terminated·Mermaid Medical A/S·July 29, 2015
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