King System , King LTS-D Kit Size 5, Sterile, REF KLTSD405, Manufacturer: King Systems Noblesville, IN. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway.
Recall
- Recall Number
- Z-1879-2011
- Event Number
- 57810
- Firm
- King Systems Corp.
- FEI Number
- 1824226
- Product Code
- CAE
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 24, 2011
- Posted
- April 4, 2011
- Terminated
- June 29, 2012
- Address
- 15011 Herriman Blvd, Noblesville, IN, 46060
Description
King System , King LTS-D Kit Size 5, Sterile, REF KLTSD405, Manufacturer: King Systems Noblesville, IN. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway.
The firms contract manufacturer reported that the products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. In rare instances the softness of the tube could cause the tube to fold over.
King Systems Corp. sent an URGENT DEVICE RECALL NOTICE letter dated January 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The letters instructed users to cease all sales of the recalled product, to notify the consignees for any product that was further distributed, and to return all recalled product to King Systems. The notice did include a response form. For questions call 317-776-6823, ext 257.
Worldwide Distribution - USA and Canada
143 cases of 10 each case