Z-0002-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2013
- Initiation Date
- December 12, 2013
- Termination Date
- November 8, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
Code Information
Part Number(s): KLTSD415 Lot Number(s): IV1V3