Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 ...

FDA Device Recall #Z-1361-2015 — Class II — February 17, 2015

Recall Summary

Recall Number Z-1361-2015
Classification Class II — Moderate risk
Date Initiated February 17, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm King Systems Corp.
Location Noblesville, IN
Product Type Devices
Quantity 900 units

Product Description

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 for Recall

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.

Distribution Pattern

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

Lot / Code Information

Part number 7169 Lot number 1737171

Other Recalls from King Systems Corp.

Recall # Classification Product Date
Z-0709-2014 Class II King Systems KLTSD414 Quantity, 5 PER CA... Dec 13, 2013
Z-0002-2014 Class II King LTS-D Oropharyngeal Airways Product U... Dec 12, 2013
Z-2255-2013 Class III King LT-D Oropharyngeal Airways The King LT-... Sep 3, 2013
Z-0420-2013 Class II KING LAD SILI CONE SINGLE USE, King Systems, 10... Nov 2, 2012
Z-0427-2013 Class II KING LAD Flexible ClearSeal SINGLE USE, King Sy... Nov 2, 2012

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.