Recall Z-0529-2008 ยท NFB Conserver, Oxygen
Superior Products Inc
Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144
| Date | Jan 23, 2008 (initiated Oct 19, 2007) |
| Status | Terminated |
| Reason | Leakage: Device was leaking oxygen |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051988 | OXY-SERVE II OXYGEN CONSERVING REGULATOR Superior Products, Inc., Sep 21, 2005 |