Medical Devices Recalls

Particulate matter found inside the fluid path.

The single leg of the PAY connector has been observed to become detached.

Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line

If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock

Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line

These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.

Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system

Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system

While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.

Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.

Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.

The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.

Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.

Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.

A software issue may lead to ventilator inoperative situations.

HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.

Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen.

Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.

An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius XPOSE 3 Access Device and XPOSE 4 Access Device.

A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.