Product Recall
Harvard Drug Group, Cardinal Health voluntarily recall eye drop products
The Harvard Drug Group and Cardinal Health have initiated voluntary recalls on certain over-the-counter ophthalmic products after the FDA warned about unsanitary conditions in the manufacturing facility.
ALK-Abelló withdraws lot of pecan nut allergen extract
ALK-Abelló has voluntarily withdrawn lot No. 0003963971 of its pecan nut allergen extract due to false-negative skin test results, including a case of life-threatening anaphylaxis, according to an FDA MedWatch alert.
FDA warns certain MSM eye drops have bacterial, fungal contamination
The FDA has issued a warning to consumers not to purchase and to immediately stop use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops because of bacterial and fungal contamination.
Abiomed recalls instructions for use for right heart pump due to risk for blood clots
Abiomed announced a recall of the labeling for its right heart pump system catheter because its instructions for use do not appropriately address precautions for patients with anticoagulation clotting time below recommended value.
FDA designates recall of two intra-aortic balloon pumps as class I
The FDA announces a recall of intra-aortic balloon pumps manufactured by Datascope/Maquet/Getinge due to risk for unexpected shutdown due to electrical failure in the power management or solenoid boards.
FDA identifies GE HealthCare recall of sensors for defibrillators as class I
GE HealthCare announced a recall of arterial oxygen saturation sensors due to a malfunction that may reduce the amount of energy sent to the heart during defibrillation without notification to the care provider.
Abiomed recalls LVADs for motor damage risk after contact with TAVR stent
Abiomed announced a recall of its left ventricular assist device due to instructions for use that do not adequately address device use in patients who have undergone transcatheter aortic valve replacement.
Abbott recall of LAAO catheters designated class I
Abbott announced a recall of its cardiac catheter used in procedures for left atrial appendage occlusion due to risk for air embolism, potentially causing stroke or death.
FDA issues two class I recalls involving ventilators
The FDA has issued class I recalls, the most serious kind, for two different ventilators.
Cipla recalls six batches of albuterol inhalers for container defect
Six batches of albuterol sulfate inhalation aerosol 90 mcg (200 metered inhalation) were voluntarily recalled by the manufacturer due to container defects that may prevent them from releasing the proper dose.