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Infusion Pumps

🏥 Medical Devices • 4,350 recalls

BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

Becton Dickinson &

Class I - Dangerous

May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain

Apr 14, 2020 Infusion Pumps Nationwide View Details →

BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

Becton Dickinson &

Class I - Dangerous

May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain

Apr 14, 2020 Infusion Pumps Nationwide View Details →

Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.

Cardinal Health

Class I - Dangerous

Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.

Apr 20, 2020 Infusion Pumps Nationwide View Details →

DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Merit Medical Systems

Class I - Dangerous

Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.

Feb 13, 2020 Infusion Pumps Nationwide View Details →

VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.

Ortho-Clinical Diagnostics

Class I - Dangerous

The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.

Apr 1, 2020 Infusion Pumps Nationwide View Details →

Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The Magstim Company Limited

Class I - Dangerous

It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.

Mar 23, 2020 Infusion Pumps Nationwide View Details →

VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.

Ortho-Clinical Diagnostics

Class I - Dangerous

The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.

Apr 1, 2020 Infusion Pumps Nationwide View Details →

Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The Magstim Company Limited

Class I - Dangerous

It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.

Mar 23, 2020 Infusion Pumps Nationwide View Details →
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