Medical Devices Recalls

Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)

CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.

Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.

Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.

The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.

Savaria Concord Lifts has decided to initiate a recall of the Stairfriend, because of product defect. The product defect relates to poor quality of welding holding the seat post .

Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.

Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.

BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms are correctly recovered.

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not affected. This anomaly may cause the OSR customer system to incorrectly switch the columns of the truth table on the users display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. BD is able to trace the issue to a limited number of instruments that have software version 4.44A installed. Note that the problem only affects customers that are either creating a new UDP with Result Logic or modifying the Result Logic of an existing UDP.

Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.

Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame and could lead to a pressure injury.

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.