Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.
FDA device recall Z-1068-05 · posted 2005-08-03 · Terminated
Recall details
- Recalling firm
- Chad Therapeutics Inc
- Reason for recall
- "Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.
- Action taken
- Firm recalled via email and letter on 3/25/2005. Firm is requesting returns of all units. Recall is on-going and is to the user or patient level.
- Root cause
- Other
- Status
- Terminated
- Product code
- BZD
- Quantity affected
- ***244 units***
- Distribution
- Nationwide and to Canada, Sweden, Norway***
- Date initiated
- 2005-03-25
- Date posted
- 2005-08-03
- Date terminated
- 2006-08-30
- Location
- Chatsworth, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 (K003455) | Chad Therapeutics, Inc. | 2000-12-06 |
| CHAD THERAPEUTICS OXYMATIC MODEL 401 (K000890) | Chad Therapeutics, Inc. | 2000-06-16 |