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 Recall Z-0709-2014 · Posted 2014-01-10
Recalling FirmKing Systems Corp.
Recall StatusTerminated
Product CodeCAE
Date Initiated0013-12-13
Date Terminated2014-05-15
Product Quantity108 cases( 540 products)
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.
Firm Action
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 [email protected]. Call the customer service representative (800.262.8673) to arrange for credit of your affected product(s).
Root Cause
Labeling Change Control
Distribution Pattern
Distributed in the states of CA, NY
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.