Drug recall
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized…
FDA recall event 87642 · Class II · Smiths Medical ASD Inc.
Key facts
| Event ID | 87642 |
|---|---|
| Recall numbers | Z-1515-2021, Z-1516-2021 |
| Recalling firm | Smiths Medical ASD Inc. |
| Product type | Devices |
| Products | ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients., Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels. |
| Initiation date | Mar 31, 2021 |
| Report date | May 5, 2021 |
| Termination date | Jan 31, 2023 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 3012307300 |
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: