Drug recall
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N…
FDA recall event 85962 · Class I · CareFusion 303, Inc.
Key facts
| Event ID | 85962 |
|---|---|
| Recall numbers | Z-2939-2020 |
| Recalling firm | CareFusion 303, Inc. |
| Product type | Devices |
| Products | BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an… |
| Initiation date | Aug 4, 2020 |
| Report date | Sep 16, 2020 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2016493 |
At a glance
- 1–9 Products in this recall
- 10–99 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: