The Recall Desk
HighFDA (Devices)·Z-0709-2014·Announced 2014-01-22

King Systems Recalls Supraglottic Airway Kits Due to Incorrect Component

King Systems Corp. is recalling King LTSD Kit Size 4 supraglottic airway devices because some packages contained KLTD214 airways that lack a required gastric suction tube lumen.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a critical functional component (gastric suction lumen) is missing, creating a risk of harm during anesthesia, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

King Systems Corp. is recalling 108 cases (540 products) of King LTSD Kit Size 4 supraglottic airway devices. The recall is due to the discovery that KLTD214 airways were found inside KLTSD414 packages. The KLTSD414 airway is designed with a lumen for the use of a gastric suction tube, whereas the KLTD214 airway does not include this lumen.

The affected products are intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration. The specific lot number involved is I15LB. The products were distributed in the states of California and New York.

Healthcare providers and consumers should stop using the affected King LTSD Kit Size 4 devices and contact King Systems Corp. for further instructions or a replacement.

The recalled product

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 Lubri
Manufacturer
King Systems Corp.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number(s): I15LB

Distribution

Distributed in 2 states: