FDA recall Z-1516-2021

Smiths Medical ASD Inc. · Class II · device

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 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.

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.

Key facts

Status
Terminated
Initiation date
2021-03-31
Report date
2021-05-05
Termination date
2023-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1516-2021