FDA Device recall Z-1516-2021
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler c…
- FDA Device
- Class II
- terminated
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler c… by Smiths Medical Asd, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1516-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-31 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Device Model Number: 11-1122; Lot Number: 3809856 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1516-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.