Class 2 Device Recall Bag Tee Assembly

• Date Initiated by Firm: August 26, 2008
• Date Posted: October 31, 2008
• Recall Status: Terminated on September 24, 2010
• Recall Number: Z-0228-2009
• Recall Event ID: 49492
• 510(K)Number: K062155 K923781
• Product Classification: Flowmeter - Product Code CAX
• Product: Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a connection function for complete delivery of mixed gases to the breathing circuit portion of the gas scavenging apparatus. The Bag Tee assembly features a non-breathing valve and an Emergency Air Intake located on the bag tee which comply with the American Dental Association guidelines.
• Code Information: Model P1407A
• Recalling Firm/ Manufacturer: Porter Instrument Co Inc; 245 Township Line Rd; Hatfield PA 19440
• For Additional Information Contact: Dental Customer Service; 800-457-2001
• Manufacturer Reason for Recall: inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas
• FDA Determined Cause: Employee error
• Action: On 9/2/08, the firm issued an Important Field Correction Notice to their customers informing them of the problem and how to determine if their product was defective and needed to be returned. Contact Porter at 1-800-457-2001 and ask for Dental Customer and refer to the Bag Tee Field Correction Notice.
• Quantity in Commerce: 220 units
• Distribution: Nationwide
• 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 = CAX