Class 2 Device Recall KimberlyClark/Ballard TRACH CARE

• Date Initiated by Firm: November 30, 2005
• Date Posted: January 11, 2006
• Recall Status: Terminated on September 06, 2006
• Recall Number: Z-0374-06
• Recall Event ID: 34218
• Product Classification: Catheters, Suction, Tracheobronchial - Product Code BSY
• Product: Kimberly-Clark/Ballard TRACH CARE* - 72 Wet Pak* for Adults * Closed Suction System with Saline Vials * Diameter 14 Fr (4.6 mm), Length 30.5 cm (12 in) * Rx Only * Single Use * Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA.
• Code Information: Catalog number 8308, Lot number 318065
• Recalling Firm/ Manufacturer: Kimberly-Clark Corporation; 1400 Holcomb Bridge Rd; Roswell GA 30076
• Manufacturer Reason for Recall: The integrity of the sterile unit package may become compromised.
• FDA Determined Cause: Other
• Action: Consignees were notified via certified mail, return receipt on 11/30/2005. The neonatal recall was faxed to the two consignees with a method to return product.
• Quantity in Commerce: 52 cases (20 units per case)
• Distribution: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MD, MO, MN, NJ, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WV, WY.
• 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.