Medical Devices Recalls

CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.

The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Report of the product penetrating the sterile barrier; this could render the product unsterile.

STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked.

Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c

Product may not have been manufactured pursuant to a validated process protocol and CGMP.

KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to.

An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.

Straps may separate from the foam pad.

Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.

Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..

Report of the product penetrating the sterile barrier; this could render the product unsterile.

When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not operational for clinical use. This problem occurs randomly.