Other Medical Devices Recalls

NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - 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 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 08-4231-0 - 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 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 drums, Model Number 13-2201-5 - 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 →

CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000

Medtronic

Class I - Dangerous

Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.

Nov 12, 2020 Other Medical Devices Nationwide View Details →

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - 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 08-4231-0 - 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 08-2351-8 - 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 drums, Model Number 13-2251-0 - 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 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 08-1301-4 - 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 →

Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

Remel

Class I - Dangerous

The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.

Dec 10, 2020 Other Medical Devices View Details →

Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707

Cook Medical

Class I - Dangerous

A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.

Dec 16, 2020 Other Medical Devices Nationwide View Details →

Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-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 →

Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-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 drums, Product Code 13-2251-0 - 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 →

VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.

Baxter Healthcare

Class I - Dangerous

VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.

Dec 11, 2020 Other Medical Devices Nationwide View Details →

NaturaLyte Liquid Acid concentrate bottles, Model Number 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 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 08-3251-9 - 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 →

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 →