Class 1 Device Recall Premie Pack

• Date Initiated by Firm: September 22, 2009
• Date Posted: November 12, 2009
• Recall Status: Terminated on August 03, 2010
• Recall Number: Z-0105-2010
• Recall Event ID: 53550
• Product Classification: Tracheal tube - Product Code BTR
• Product: Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110. Aspiration tray containing Portex uncuffed pediatric sized tracheal tubes.
• Code Information: Lots 901087, 903267, 907307, 910297, 901218, 908258, 2009020990 and 2009022390.
• Recalling Firm/ Manufacturer: Centurion Medical Products; 301 Catrell Dr; Howell MI 48843-1703
• For Additional Information Contact: 517-545-1156
• Manufacturer Reason for Recall: The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete obstruction of the airway.
• FDA Determined Cause: Process control
• Action: The firm's sales representative was notified of the recall on September 22, 2009 via email and the sole customer was notified by letter dated September 23, 2009. All product was removed from the customer account on September 28, 2009 and returned to the recalling firm.
• Quantity in Commerce: 650
• Distribution: Illinois.
• 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.