Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0228-2009

Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a connection function for...

Precision Fluidics Division Parker Hannifin Corp. / initiated 2008-08-26 / Terminated / root cause: manufacturing process

Porter Instrument Co Inc began a recall of 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... on . The reason FDA records is "inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0228-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Precision Fluidics Division Parker Hannifin Corp.
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.
Product code
CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Reason for recall
inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas
Root cause tag
manufacturing process
FDA root 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
Product codes and lots
Model P1407A