King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part N

FDA device recall Z-0709-2014 · posted 2014-01-10 · Terminated

Recall details

Recalling firm

King Systems Corp.

Reason for recall

KLTD214 airways found inside KLTSD414 packages. The KLTSD414 airway has a lumen for use of a gastric suction tube; the KLTD214 airway does not include a lumen for a gastric suction tube.

Action taken

December 13, 2013 Urgent Recall Notices were sent to all Direct Accounts identifying the recalled item, risks associated with the incorrectly labeled product and asking customers to stop use, quarantine and destroy any recalled product on hand. Customers were asked to froward the notifcation if the product was further distributed and FAX the completed recall acknowledgement form to 317-776-5175 or email wnethercutt@kingsystems.com. Call the customer service representative (800.262.8673) to arrange for credit of your affected product(s).

Root cause

Labeling Change Control

Status

Terminated

Product code

CAE

Quantity affected

108 cases( 540 products)

Distribution

Distributed in the states of CA, NY

Date initiated

0013-12-13

Date posted

2014-01-10

Date terminated

2014-05-15

Location

Noblesville, IN