11 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals.
FDA Recall
Terminated
·TiSport, Llc·Product code IOR·July 5, 2011
TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.
FDA Recall
Terminated
·TiSport, Llc·Product code IOR·September 11, 2018
TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.
FDA Enforcement
Class II
·Terminated·TiSport, Llc·August 28, 2019
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code KNW·April 24, 2015
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 3, 2015
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 12, 2013
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·April 22, 2020
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OEQ·July 9, 2018
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
FDA Recall
Terminated
·American Optisurgical Inc·Product code OJU·April 30, 2013
Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI. The device is intended for use during percutaneous biopsy and drainage procedures to obtain tissues or fluid specimens.
FDA Recall
Terminated
·Inrad, Inc·Product code GAA·December 20, 2010
PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician.
FDA Recall
Terminated
·Medtronic Navigation Kochav Yokneam 1 Hamelacha St. Yokne'am Ilit Israel·Product code LNH·June 20, 2016