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.

Code information: Device Model Number: 11-1122; Lot Number: 3809856

Distribution pattern: 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.