Recall Z-0002-2014 ยท CAE Airway, Oropharyngeal, Anesthesiology
King Systems Corp.
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.
| Date | Oct 1, 2013 (initiated Dec 13, 12) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Error in labeling |
| 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. |
| Quantity | 1 case; 5 units |
| Distribution | USA Nationwide Distribution in the state of NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.