Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a connection function for complete delive
FDA device recall Z-0228-2009 · posted 2008-10-31 · Terminated
Recall details
- Recalling firm
- Porter Instrument Co Inc
- Reason for recall
- inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- CAX
- Quantity affected
- 220 units
- Distribution
- Nationwide
- Date initiated
- 2008-08-26
- Date posted
- 2008-10-31
- Date terminated
- 2010-09-24
- Location
- Hatfield, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIGITAL MXR-D FLOWMETER (K062155) | Porter Instrument Co., Inc. | 2006-11-09 |
| MXR-2000 FLOWMETER (K923781) | Porter Instrument Co., Inc. | 1993-06-10 |