Colorado recalls

The possibility for this product that is intended for demonstration purposes only to be placed in patients.

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Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

The impacted lot may not meet the required tensile strength specification.

The impacted lot may not meet the required tensile strength specification.

Potential contamination of Salmonella Richmond

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis

Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.