All Recalls

Subpotent Drug: Low assay result observed during long-term stability testing.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

CGMP Deviations: potential for trace amounts of product carryover.

Short Fill

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Short Fill

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.

Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2

Potential for pilot balloon non-inflation or cuff non-deflation.

Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.

Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.