Recall Z-1361-2015— King Systems Corp.

Class II FDA medical device recall by King Systems Corp., initiated 2015-02-17, terminated 2015-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desired.. Reason: Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector without Suction port. If the incorrect component is not identified prior to clinical use, the incorrect connector would be replaced during the case without risk to the patient and could result in a short delay of the procedure..

Recalling firm

King Systems Corp.

Classification

Class II

Status

Terminated

Initiated

2015-02-17

Terminated

2015-10-27

Firm location

Noblesville, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.