Drug recall
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
FDA recall event 87470 · Class I · Tenacore LLC
Key facts
| Event ID | 87470 |
|---|---|
| Recall numbers | Z-1331-2021, Z-1332-2021 |
| Recalling firm | Tenacore LLC |
| Product type | Devices |
| Products | Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410, Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of… |
| Initiation date | Feb 25, 2021 |
| Report date | Apr 14, 2021 |
| Termination date | Aug 5, 2024 |
| City | Santa Ana |
| State | CA |
| Country | United States |
| FEI number | 3008403701 |
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: