Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, O
FDA device recall Z-0529-2008 · posted 2008-01-23 · Terminated
Recall details
- Recalling firm
- Superior Products Inc
- Reason for recall
- Leakage: Device was leaking oxygen
- Action taken
- A Voluntary Medical Device Recall notification was delivered by certified mail on or about 10/19/2007, to all consignee's; "bill to" and "sent to." Consignee's are asked to contact their customers (if any), notify them of the recall, and return all implicated products to Superior Products.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- NFB
- Quantity affected
- 125
- Distribution
- Worldwide-USA including states of CA, FL, IA, IN, KY, OH, SC, TX, and WA. and countries of Singapore, Mexico City, MX, and Turkey
- Date initiated
- 2007-10-19
- Date posted
- 2008-01-23
- Date terminated
- 2012-04-25
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXY-SERVE II OXYGEN CONSERVING REGULATOR (K051988) | Superior Products, Inc. | 2005-09-21 |