Drug recall
Level 1 H-1200 H30 andlor H-31B Fast Flow Fluid Warmer with Level 1 H-30, H-3 1 A, andlor H-3 1 B Air…
FDA recall event 37584 · Class II · Smiths Medical ASD, Inc.
Key facts
| Event ID | 37584 |
|---|---|
| Recall numbers | B-1258-07 |
| Recalling firm | Smiths Medical ASD, Inc. |
| Product type | Biologics |
| Products | Level 1 H-1200 H30 andlor H-31B Fast Flow Fluid Warmer with Level 1 H-30, H-3 1 A, andlor H-3 1 B Air DetectorIClamp |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Fluid Warmers, with defective air detector clamping mechanisms which could cause air embolism, were distributed. |
| Initiation date | Feb 22, 2007 |
| Termination date | Dec 3, 2008 |
| City | Rockland |
| State | MA |
| Country | United States |
| FEI number | 1221261 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports