Device recall
Z-0057-2008: ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill)…
FDA device recall · Class II · I-Flow Corporation
Key facts
| Recall number (Z-number) | Z-0057-2008 |
|---|---|
| Recall event | 44933 |
| Product | ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A. |
| Product code | MED |
| Recalling firm | I-Flow Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2009 |
| 510(k) numbers | K932740 |
| FEI number | 3011270181 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database