Connector, Airway (extension)

ErgoStar CM 40

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

ErgoStar CM 45,

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

ErgoStar CM 55,

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

ErgoStar CM 60,

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P

Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.

smiths medical portex, 15mm Double Swivel Connector:

Uncertainty in the seal integrity of the sterile packaging.

DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits

DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits

DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50

These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.