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.
FDA Recall Z-2255-2013 · Posted 2013-09-19
Recalling FirmKing Systems Corp.
Recall StatusTerminated
Product CodeCAE
Date Initiated2013-09-03
Date Terminated2014-04-15
Product Quantity9 cases; 45 products
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.
Firm Action
King Systems notified one consignee who received the affected product verbally on August 7, 2013, via email and an Urgent Medical Device Recall - Immediate Action Required notification on September 3, 2013. The Urgent Medical Device Recall - Immediate Action Required notification described the product and issue as well as includes a response form for the consignee to complete and send back to King Systems via FAX to 317-776-5175, or email to [email protected]. Questions regarding the notice are directed to: King Systems customer service representative at 800.642.5464, Monday through Friday 8:00am- 5pm EDT.
For questions regarding this recall call 317-776-6823.
Root Cause
Labeling mix-ups
Distribution Pattern
Distributed in NY.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.