Medical Devices Recalls

Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

There is a potential for the outer white Tyvek lid to debond from the sealed package.

Endotoxin levels exceeded allowable limits.

Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays

When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range

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Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.

All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Due to an uptick of complaints associated with premature needle retraction of blood collection system.

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.

The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

There is a potential to display incomplete patient imaging study.

Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)

The package contents and package labeling do not match.