Recall Z-0228-2009 ยท CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Porter Instrument Co Inc
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.
| Date | Oct 31, 2008 (initiated Aug 26, 2008) |
| Status | Terminated |
| Reason | inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas |
| 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 | 220 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |