Recall Z-0709-2014— King Systems Corp.
Class II · Terminated
Class II FDA medical device recall by King Systems Corp., initiated 2013-12-13, terminated 2014-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- King Systems Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-13
- Terminated
- 2014-05-15
- Firm location
- Noblesville, IN, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.