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Potential contamination with Listeria monocytogenes.
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
Medline medical procedure kits, containing Medtronic Aortic Root Cannula
The firm received complaints of spoilage and illness with the use of the products.
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
The RSV target may give a late Ct value and could potentially not pass QC.
IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Presence of Particulate Matter
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.