Cardinal Health Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product recall — FDA Z-2284-2021
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
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Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results,…
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section…
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section…
There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.
Undeclared allergens in salad mix - milk and wheat. Cheese and croutons are packed separately and clearly visible to consumer.
Undeclared wheat and tuna
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of…
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of…
Labeling: Not elsewhere classified: Mislabeling
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
SubPotent: Out of Specification
Non-Sterility: firm's third party lab confirmed microbial contamination.
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Volvo Car USA, LLC (Volvo Car) is recalling certain 2021 XC40, XC 40 Recharge, V60CC, V90, V90CC, XC90, and 2021-2022 V60, XC60, S60 vehicles. The seat belt automatic locking retractors may…
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