Recall Z-2255-2013— King Systems Corp.
Class III · Terminated
Class III FDA medical device recall by King Systems Corp., initiated 2013-09-03, terminated 2014-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: King LT-D Oropharyngeal Airways The King LT-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: Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious..
- Recalling firm
- King Systems Corp.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-09-03
- Terminated
- 2014-04-15
- Firm location
- Noblesville, IN, United States
Product description
King LT-D Oropharyngeal Airways The King LT-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
Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
Data sourced from openFDA. This site is unofficial and independent of the FDA.