Z-2255-2013 Class III Terminated
FDA device recall Z-2255-2013 was initiated by King Systems Corp. on September 3, 2013 and is designated Class III. Reason for recall: 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 t… The recall status is terminated (terminated April 15, 2014). Affected quantity: 9 cases; 45 products.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2013
- Initiation Date
- September 3, 2013
- Termination Date
- April 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 cases; 45 products
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Distributed in NY.
Code Information
Part Number KLTD2125 Lot Number I10RG