Medical Devices Recalls

Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling.

Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally.

Ultrasound needles may be defective and leak at the needle hub.

Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.

The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.

During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software v

Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components that could result in a latent failure.

Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

A femoral component containing pegs was found in a box for the pegless version.

High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the Study List.

A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates.

A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

There is a potential that the specified mucus specimen traps are not sterile. Use of the affected products may result in the contamination of patient specimens.

Ultrasound needles may be defective and leak at the needle hub.

CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.

Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.

This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.

Possible breach in sterile barrier for inner and outer bags of the product.