FDA-Device2021-05-05Class II
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.
Hazard
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.
Sold states
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.
Affected count
250 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1516-2021Don't want to check this manually?
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