Drug recall
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers…
FDA recall event 88501 · Class II · Welch Allyn Inc Mortara
Key facts
| Event ID | 88501 |
|---|---|
| Recall numbers | Z-0011-2022 |
| Recalling firm | Welch Allyn Inc Mortara |
| Product type | Devices |
| Products | ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The devices malfunction under specific operator workflows. |
| Initiation date | Sep 3, 2021 |
| Report date | Oct 13, 2021 |
| City | Milwaukee |
| State | WI |
| Country | United States |
| FEI number | 2183461 |
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: