Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035
TELEFLEX
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.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040
TELEFLEX
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.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055
TELEFLEX
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.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065
TELEFLEX
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.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070
TELEFLEX
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.
MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
Megadyne Medical 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.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780045
TELEFLEX
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;
Implant Direct Sybron Manufacturing
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.