Recall Z-0709-2014 ยท CAE Airway, Oropharyngeal, Anesthesiology
King Systems Corp.
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 p
| Date | Jan 10, 2014 (initiated Dec 13, 13) |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | December 13, 2013 Urgent Recall Notices were sent to all Direct Accounts identifying the recalled item, risks associated with the incorrectly labeled product and asking customers to stop use, quarantine and destroy any recalled product on hand. Customers were asked to froward the notifcation if the product was further distributed and FAX the completed recall acknowledgement form to 317-776-5175 or email wnethercutt@kingsystems.com. Call the customer service representative (800.262.8673) to arrange for credit of your affected product(s). |
| Quantity | 108 cases( 540 products) |
| Distribution | Distributed in the states of CA, NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.