Class 2 Device Recall Air Lon Nylon Laryngectomy Tubes

• Date Initiated by Firm: August 05, 2004
• Date Posted: September 15, 2004
• Recall Status: Terminated on November 23, 2005
• Recall Number: Z-1470-04
• Recall Event ID: 29920
• Product Classification: Tube Tracheostomy And Tube Cuff - Product Code JOH
• Product: Laryngectomy Tubes, Air Lon Nylon, item number1050170 size 8 and item number 1050172 size 10.
• Code Information: all lots ending with S or T
• Recalling Firm/ Manufacturer: Premier Dental Products Co; 1710 Romano Dr; Plymouth Meeting PA 19462-2822
• For Additional Information Contact: Vince D'Alessandro; 610-239-6015
• Manufacturer Reason for Recall: foreign objects (polishing stones) in the tubes
• FDA Determined Cause: Other
• Action: The recalling firm issued a recall letter dated 8/5/04 to their distributors. The letter informs the accounts of the problem and the need to return any affected product. The recalling firm issued a second letter dated 8/11/04 to the distributors with instructions to conduct a sub-recall.
• Quantity in Commerce: 22,324 tubes
• Distribution: The products were shipped to 45 distributors nationwide. The products were also shipped to Canada, Malaysia, Taiwan, Thailand, Turkey, and the Dominican Republic.
• 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.