Medical Devices Recalls

The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)

One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.

Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.

Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.

ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)

A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocation can result in non-target tissue being sampled rather than target tissue. May result in an incorrect diagnosis.

Defect: A hole or crack was found which may cause air to leak.

Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.

In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr

The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.

Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.

Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.

Incorrect CT to ED when using the Monaco Image Statistics Tool.

Incorrect size printed on the Milex Pessary Kit packaging label

Reports of formation of char adherent to the proximal part of the distal tip electrodes

Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion.

PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.