—#134354

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.

FDA product code: BZA — Connector, Airway (Extension)
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Part number 7169 Lot number 1737171

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Kingsystems sent an Urgent Medical Device Recall letter dated February 17, 2015 to affected customers. The letter identified the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call your King Systems customer service representative at 800.642.5464.

Recalling firm

Firm: King Systems Corp.
Address: 15011 Herriman Blvd, Noblesville, Indiana 46060-4253

Distribution

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

Timeline

Recall initiated: 2015-02-17
Posted by FDA: 2015-04-01
Terminated: 2015-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134354. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.