FDA Recall Terminated

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.

Recall: Z-0228-2009 · Initiated August 26, 2008

Recall

Recall Number
Z-0228-2009
Event Number
49492
Firm
Porter Instrument Co Inc
FEI Number
2518157
Product Code
CAX
Status
Terminated
Root Cause
Employee error
Initiated
August 26, 2008
Posted
October 31, 2008
Terminated
September 24, 2010
Address
245 Township Line Rd, Hatfield, PA, 19440

Description

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.

Reason

inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas

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.

Distribution

Nationwide

Quantity

220 units