Recall Z-0228-2009
Porter Instrument Co Inc · initiated August 26, 2008
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.
Codes / lots: Model P1407A
Reason for recall
inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0228-2009
- Initiated
- August 26, 2008
- Posted by FDA
- October 31, 2008
- Terminated
- September 24, 2010
- Product code
- CAX – Flowmeter, Tube, Thorpe, Back-Pressure Compensated
- Quantity
- 220 units
- Distribution
- Nationwide
- Recalling firm
- Porter Instrument Co Inc, Hatfield, PA