All Recalls

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Firm has received reports of patient burns in surgical procedures where device was used.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.