Medical Devices Recalls

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

Nov 23, 2020 Other Medical Devices Nationwide View Details →

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Philips North America

Class I - Dangerous

A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.

Nov 19, 2020 Diagnostic Equipment Nationwide View Details →

Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).

Siemens Medical Solutions USA

Class I - Dangerous

After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.

Sep 9, 2020 Infusion Pumps View Details →

Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

Nov 23, 2020 Other Medical Devices Nationwide View Details →

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.

Boston Scientific

Class I - Dangerous

Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.

Nov 17, 2020 Surgical Instruments Nationwide View Details →

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

EXOGEN Ultrasound Coupling Gel

Bioventus

Class I - Dangerous

Product may contain white particulates that are microbial in nature.

Dec 17, 2020 Other Medical Devices Nationwide View Details →

icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.

ICU Medical

Class I - Dangerous

Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.

Nov 9, 2020 Diagnostic Equipment Nationwide View Details →

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292

Ortho Clinical Diagnostics

Class I - Dangerous

Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

Dec 15, 2020 Infusion Pumps Nationwide View Details →

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

Nov 23, 2020 Other Medical Devices Nationwide View Details →

visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.

VISBY MEDICAL

Class I - Dangerous

Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.

Dec 5, 2020 Diagnostic Equipment Nationwide View Details →

Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

Nov 23, 2020 Other Medical Devices Nationwide View Details →

Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

Nov 23, 2020 Other Medical Devices Nationwide View Details →

Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Nov 7, 2020 Other Medical Devices Nationwide View Details →

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings

Class I - Dangerous

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

Nov 23, 2020 Other Medical Devices Nationwide View Details →