Class 2 Device Recall Tracheobronchial suction catheter.

• Date Initiated by Firm: June 13, 2003
• Date Posted: August 06, 2003
• Recall Status: Terminated on November 24, 2003
• Recall Number: Z-1081-03
• Recall Event ID: 26542
• 510(K)Number: K872621
• Product Classification: Catheters, Suction, Tracheobronchial - Product Code BSY
• Product: Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates
• Code Information: Catalog No: 1925, Lot Numbers: 215499, 218054.
• Recalling Firm/ Manufacturer: Ballard Medical Products; 12050 S Lone Peak Parkway; Draper UT 84020
• For Additional Information Contact: 801-572-6800
• Manufacturer Reason for Recall: Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
• FDA Determined Cause: Other
• Action: All consignees were notified by letter on 06/13/2003.
• Quantity in Commerce: 140 units
• Distribution: Nationwide and to Belgium, Canada, Colombia, Germany, Japan, Norway, South Africa, Sweden, Switzerland, Turkey, United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BSY and Original Applicant = BALLARD MEDICAL PRODUCTS