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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.

FDA Recall Z-0228-2009 · Posted 2008-10-31

Recalling FirmPorter Instrument Co Inc
Recall StatusTerminated
Product CodeCAX
Date Initiated2008-08-26
Date Terminated2010-09-24
Product Quantity220 units

Reason for Recall

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062155DIGITAL MXR-D FLOWMETERPorter Instrument Co., Inc. · 2006-11-09K923781MXR-2000 FLOWMETERPorter Instrument Co., Inc. · 1993-06-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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