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U.S. Department of Health and Human Services

Class 2 Device Recall Bag Tee Assembly

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  Class 2 Device Recall Bag Tee Assembly see related information
Date Initiated by Firm August 26, 2008
Date Posted October 31, 2008
Recall Status1 Terminated 3 on September 24, 2010
Recall Number Z-0228-2009
Recall Event ID 49492
510(K)Number K923781  K062155  
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 2		 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 and Original Applicant = PORTER INSTRUMENT CO., INC.
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