Medical Devices Recalls

Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.

Vials labeled for the prescriptions contained incorrect lenses

Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.

After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.

Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.

The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

Incorrect use-by date on the device registration/patient file labels.

Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.

Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.

It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It also showed the OK button to reacquire image data form the FPD, and the Cancel button to cancel the reacquisition. When the operator selects the OK button, the same message window appears. The operator then repeated the same operation several times and finally selected the Cancel button to quit the reacquisition mode.

The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.

Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the non-sterile portion of the CDS assembly. This component should have been placed inside the sterile portion of the pack where it would have subsequently been exposed to an ethylene oxide sterilization process. This component was not placed in the sterile portion of the pack and was not sterilized, resulting in the inadvertent release of this item in a non-sterile state. The contents of the sterile kit were properly sterilized and the remaining contents of the non-sterile subassembly had the appropriate sterility status based on their intended use.

The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.

The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.

The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.

Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.

One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.