King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg

FDA device recall Z-0002-2014 · posted 2013-10-01 · Terminated

Recall details

Recalling firm

King Systems Corp.

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

Action taken

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

Status

Terminated

Product code

CAE

Quantity affected

1 case; 5 units

Distribution

USA Nationwide Distribution in the state of NY

Date initiated

0012-12-13

Date posted

2013-10-01

Date terminated

2013-11-08

Location

Noblesville, IN