Medical device recalls

Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.

Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.