King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414, Manufacturer: King Systems Noblesville, IN. Ventilation d

FDA device recall Z-1878-2011 · posted 2011-04-04 · Terminated

Recall details

Recalling firm

King Systems Corp.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

CAE

Quantity affected

138 cases 5 units per case, 690 units

Distribution

Worldwide Distribution - USA and Canada

Date initiated

2011-01-24

Date posted

2011-04-04

Date terminated

2012-06-29

Location

Noblesville, IN