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
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