Double Swivel Connector with Suction Port Connector recalled over labeling errors

Recall date

February 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

King Systems Corp. recalls Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway…

Recall number

Z-1361-2015

FDA classification

Class II

Brand / firm

King Systems Corp.

Sold / distributed

US Nationwide in the states of IL, IN, KY, MI, PA, and TN

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.