MEDLINE INDUSTRIES, LP - Northfield - Class 2 Recall
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI LITHOTOMY p. MAJOR CDS-1 q. MINOR CDS-1 r. VASCULAR CDS-4 s. SEPTOPLASTY CDS t. DENTAL CDS u. MINOR GENERAL CDS v. CUH UROLOGY LITHOTOMY CDS w. CUH UROLOGY OPEN CDS x. CUH LIVER TRANSPLANT CDS y. THORACOTOMY CDS z. XI THORACIC ROBOTIC CDS aa. GENERAL CDS bb. THORACIC CDS cc. MINOR PROCEDURE dd. EXTREMITY CDS ee. D...
Source: Medical Device Recalls - February 7, 2023 Category: Medical Devices Source Type: alerts
Microgenics Corporation - QMS Everolimus Assay - Class 2 Recall
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant p...
Source: Medical Device Recalls - October 4, 2016 Category: Medical Equipment Source Type: alerts
SynCardia Systems Inc. - Temporary Total Artificial Heart (TAHt) with Freedom - Class 1 Recall
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2015 Category: Medical Equipment Source Type: alerts
Musculoskeletal Transplant Foundation, Inc. - Musculoskeletal Transplant Foundation Allofix Insertion Kit - Class 2 Recall
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2015 Category: Medical Equipment Source Type: alerts
Diasorin Inc. - PROTrac II Tacrolimus ELISA kit - Class 2 Recall
DiaSorin, PRO-Trac" II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 21, 2015 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Dimension Vista CSA and CSAE - Class 2 Recall
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2014 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Dimension Vista Cyclosporine Flex reagent cartridge - Class 2 Recall
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2014 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Dimension(R) TACR Flex(R) reagent cartridge (DF107) - Class 2 Recall
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2013 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - DimensionTACR (DF107) and Dimension Tacrolimus Calibrator (DC107) - Class 2 Recall
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 8, 2013 Category: Medical Equipment Source Type: alerts
