CLASS II Device recall · Reported 22 Jan 2014 · FDA Enforcement Report

KLTSD414 Quantity King Ltsd Kit Size 4 King LT(S)-Dtm recalled

King Systems is recalling KLTSD414 Quantity King Ltsd Kit Size 4 King LT(S)-Dtm supraglottic airway Identification, distributed in California, New York. The recall was initiated on 13 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number(s): I15LB

Quantity recalled108 cases( 540 products)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0709-2014
FDA event ID: 66869
Recalling firm: King Systems, Noblesville, IN
Classification: Class II
Status: Terminated
Recall initiated: 13 Dec 2013
FDA classified: 10 Jan 2014
Reported: 22 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Syringes & Needles

Timeline

13 Dec 2013	Recall initiated by company
10 Jan 2014	Classified by FDA	+28 days
22 Jan 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Distributed in the states of CA, NY

California New York

Questions about this recall

Why was it 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.

Which lots are affected?

Lot Number(s): I15LB

Where was it sold?

Distributed in the states of CA, NY

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from King Systems

All 26

Reported	Class	Recall	Company	Reason	Where
6 Nov 2024Device	CLASS II	King Ltsd,Size 2,W/Suction Port Sterile-Inserted into recalled	King Systems	Other	Nationwide
6 Nov 2024Device	CLASS II	King Ltsd,Size 2.5, W/Suction Port Sterile-Inserted into recalled	King Systems	Other	Nationwide
6 Nov 2024Device	CLASS II	King Ltsd,Size 0, W/Suction Port Non-sterile Kit-Inserted recalled	King Systems	Other	Nationwide
6 Nov 2024Device	CLASS II	King Ltsd,Size 2, W/Suction Port Non-sterile Kit-Inserted recalled	King Systems	Other	Nationwide
6 Nov 2024Device	CLASS II	King Ltsd,Size 1, W/Suction Port Non-sterile Kit-Inserted recalled	King Systems	Other	Nationwide

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