FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0228-2009
- Recalling firm
- Porter Instrument Co Inc
- 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.
- Status
- Terminated
- Initiated
- 2008-08-26
- Posted
- 2008-10-31
- Terminated
- 2010-09-24
- 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
- Lot, serial or model codes
- Model P1407A
- 510(k) numbers
- ["K062155","K923781"]
- PMA numbers
- not on file
- Product code
- CAX
- Firm FEI
- 2518157
- Firm city
- Hatfield
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28