Kentucky recalls

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

Presence of particulates in affected devices that can be deposited into breast tissue during use.

A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.

A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.

Undeclared Aspartame

foreign material (small hard plastic fragments)

Foreign material (small hard plastic fragments).

Foreign material (small hard plastic fragments).

Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.

Defective Delivery System: Missing or duplicated needles within the injection kit

Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter

Presence of Foreign substance - potential presence of metal particulate matter