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Sources: EU EUDAMED, US FDA
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The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV D.pdf.pdf
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 21, 2018
The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-000 REV D.pdf.pdf, LEO-110030100_REV D.pdf.pdf, LEO-110030110_REV D.pdf.pdf, LEO-110030120_REV D.pdf.pdf
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWS·November 28, 2017
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·May 30, 2018
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 1, 2018
Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035 Intended to provide transportation for a disabled or elderly person.
FDA Recall
Terminated
·Invacare Corporation·Product code INI·December 7, 2011
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·January 15, 2020
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 19, 2020
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·July 28, 2021
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock connector (e.g., Liberty cycler, Newton IQO cycler).
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : 75 test iQM Part Number:00027407511 150 test iQM Part Number: 00027415011 300 test iQM Part Number: 00027430011 450 test iQM Part Number: 00027445011 600 test iQM part Number: 00027360011 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code CEM·May 31, 2011
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part Number : 00027407510 150 test iQM Part Number:00027415010 300 test iQM Part Number: 00027430010 450 test iQM Part Number: 00027445010 600 test iQM Part number: 00027360010 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code CEM·May 31, 2011
Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,K05-00180G, and K05-00553F.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·October 1, 2003
Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir.
FDA Recall
Terminated
·Hospira Inc.·Product code DQO·November 2, 2004
Catheterization Kits containing Angiographic Syringes with rotator connector.
FDA Recall
Terminated
·Hospira Inc.·Product code DQO·November 2, 2004
Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-04. 6F FR6 (5-pack). Distal curve FR6. 100 cm length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.
FDA Recall
Terminated
·Boston Scientific·Product code DQO·November 20, 2007
Merit Medical Systems, Inc. Connection tubes label reading in part: CONNECTING TUBE W/ STOPCOCK 12" CATALOG NUMBER K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and drainage bag
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQO·September 29, 2009
STERIS 4085, 5085 & 5085SRT Surgical Tables
FDA Recall
Terminated
·Steris Corporation·Product code FQO·May 14, 2010
The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
FDA Recall
Terminated
·Steris Corporation·Product code FQO·June 27, 2014
Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); distributed by Stryker Communications, Flower Mound, TX 75028. The 0682-000-414 (FP Shroud version 2 reworked) is a shroud designed to cover the cabling necessary on a Stryker Version 3 Monitor when mounted on the Flat Panel Arm.
FDA Recall
Terminated
·Stryker Communications Corp·Product code FQO·September 2, 2008
Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010