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.
FDA Recall Z-0002-2014 · Posted 2013-10-01
Recalling FirmKing Systems Corp.
Recall StatusTerminated
Product CodeCAE
Date Initiated0012-12-13
Date Terminated2013-11-08
Product Quantity1 case; 5 units
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
Firm Action
King Systems notified the only one (1) consignee who received the affected product of the problem via a customer complaint. Five (5) of the five (5) affected products were destroyed by consignee.
Root Cause
Error in labeling
Distribution Pattern
USA Nationwide Distribution in the state of NY
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.