Medical Devices Recalls

Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high)

Handle could jam with the Driver due to the detachment of an internal Connector Ring.

Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

Manufacturing flaw in the sterile barrier system

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

Lack of package integrity may compromise sterility

Manufacturing flaw in the sterile barrier system

Manufacturing flaw in the sterile barrier system

Potential for sterile packaging to be compromised

There was a higher than normal incidence rate of the blade not retracting when tightening.

In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.

Potential for sterile packaging to be compromised

Potential for sterile packaging to be compromised

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.