FDAFDA · Food and drugs·Recall number Z-2255-2013
King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Published September 25, 2013 · Recall initiated: September 3, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- King Systems Corp.
- Distributor
- Distributed in NY.
- Lot
- Part Number KLTD2125 Lot Number I10RG
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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