FDAFDA · Food and drugs·Recall number Z-0002-2014
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-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 October 9, 2013 · Recall initiated: December 12, 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
On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- King Systems Corp.
- Distributor
- USA Nationwide Distribution in the state of NY
- Lot
- Part Number(s): KLTSD415 Lot Number(s): IV1V3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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