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 King Systems KLTSD414 Quantity King Ltsd Kit Size 4 King LT(S)-Dtm supraglottic airway, 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
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
- Reason category
- Sterility
- 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
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
Questions about this recall
Is KLTSD414 Quantity King Ltsd Kit Size 4 King LT(S)-Dtm supraglottic airway Identification recalled?
Yes. King Systems recalled KLTSD414 Quantity King Ltsd Kit Size 4 King LT(S)-Dtm supraglottic airway Identification on 13 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-0709-2014.
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 21 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 |
|---|---|---|---|---|---|
| Device | CLASS II | King Ltsd,Size 2,W/Suction Port Sterile-Inserted into recalled | King Systems | Sterility | Nationwide |
| Device | CLASS II | King Ltsd,Size 5, W/Suction Port Sterile-Inserted into recalled | King Systems | Sterility | Nationwide |
| Device | CLASS II | King Ltsd,Size 0, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Sterility | Nationwide |
| Device | CLASS II | King Ltsd,Size 2, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Sterility | Nationwide |
| Device | CLASS II | King Ltsd,Size 1, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Sterility | Nationwide |
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