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Sources: EU EUDAMED, US FDA
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Case Label: REORDER NO. 7303 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7303 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6039, R1 SINGLE USE WELCON BRAND Foley Catheterization Tray With 10 mL Prefilled Syringe 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFREE CONTENTS: 1200 mL Graduated Drain Tray 10 mL Prefilled Syringe Gloves Fenestrated Drape PVP Swabsticks (3) Lube Jelly Waterproof Underpad Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·January 20, 2011
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16TSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
FDA Recall
Terminated
·Covidien Llc·Product code KOD·April 30, 2020
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P18XTS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
FDA Recall
Terminated
·Covidien Llc·Product code KOD·April 30, 2020
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
FDA Recall
Terminated
·Covidien Llc·Product code KOD·April 30, 2020
P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS
FDA Recall
Terminated
·COVIDIEN LLC·Product code KOD·July 11, 2018
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code KOD·January 27, 2022
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code KOD·January 27, 2022
WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code KWI·December 27, 2019
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code KWI·December 27, 2019
BREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·July 10, 2015
Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
FDA Recall
Terminated
·Associates of Cape Cod, Inc.·Product code NQZ·August 17, 2022
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016
Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code OLO·July 18, 2016
MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016
Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016
MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code DZE·July 18, 2016
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
FDA Recall
Open, Classified
·Wright Medical Technology, Inc.·Product code KWI·August 3, 2022
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
FDA Recall
Open, Classified
·KOB GmbH Lauterstr. 50 Wolfstein Germany·Product code ITG·January 15, 2026