King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult...

FDA Device Recall #Z-0002-2014 — Class II — December 12, 2013

Recall Summary

Recall Number Z-0002-2014
Classification Class II — Moderate risk
Date Initiated December 12, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm King Systems Corp.
Location Noblesville, IN
Product Type Devices
Quantity 1 case; 5 units

Product Description

King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Reason for Recall

On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I

Distribution Pattern

USA Nationwide Distribution in the state of NY

Lot / Code Information

Part Number(s): KLTSD415 Lot Number(s): IV1V3

Other Recalls from King Systems Corp.

Recall # Classification Product Date
Z-1361-2015 Class II Double Swivel Connector with Suction Port Conn... Feb 17, 2015
Z-0709-2014 Class II King Systems KLTSD414 Quantity, 5 PER CA... Dec 13, 2013
Z-2255-2013 Class III King LT-D Oropharyngeal Airways The King LT-... Sep 3, 2013
Z-0427-2013 Class II KING LAD Flexible ClearSeal SINGLE USE, King Sy... Nov 2, 2012
Z-0425-2013 Class II KING LAD Standard 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.