Smiths Medical ASD Inc. Recall 87642
Description: 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.
Smiths Medical ASD Inc. Recall 87642 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1516-2021 |
| Event ID | 87642 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of PA and MN. The countries of Columbia, Germany, Greece, Hong Kong, Qatar, Thailand, and United Arab Emirates. |
| Quantity | 250 units |
| Recall 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. |
| Device Classification | 20210505 |
| Device Code Info | Device Model Number: 11-1122; Lot Number: 3809856 |
| Center Classification Date | 20210429 |
| Recall Initiation Date | 20210331 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | Other |
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