—#124329

Product

King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubricant 32-5332 05/10 Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration.

FDA product code: CAE — Airway, Oropharyngeal, Anesthesiology
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Lot Number(s): I15LB

Why it was recalled

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.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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).

Recalling firm

Firm: King Systems Corp.
Address: 15011 Herriman Blvd, Noblesville, Indiana 46060-4253

Distribution

Distribution pattern: Distributed in the states of CA, NY

Timeline

Recall initiated: 0013-12-13
Posted by FDA: 2014-01-10
Terminated: 2014-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124329. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.