Drug recall
1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005…
FDA recall event 64971 · Class II · Carefusion 2200 Inc
Key facts
| Event ID | 64971 |
|---|---|
| Recall numbers | Z-1947-2013 |
| Recalling firm | Carefusion 2200 Inc |
| Product type | Devices |
| Products | 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag… |
| Initiation date | Apr 22, 2013 |
| Report date | Aug 21, 2013 |
| Termination date | Jun 16, 2015 |
| City | Waukegan |
| State | IL |
| Country | United States |
| FEI number | 3008002452 |
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 · Source date: