Reported Sep 25, 2013 · Terminated
King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled…
King Systems Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: King Systems Corp. · 15011 Herriman Blvd · Noblesville, IN · 46060-4253
Is this the product you have?
- 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.
- Lot codes and dates
- Part Number KLTD2125 Lot Number I10RG
- Amount recalled
- 9 cases; 45 products
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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