medical Class II Updated 2021-05-05

Smiths Medical ASD Inc. recalls ACE MDI Spacer with Small Mask - Product Usage: designed to

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Device Model Number: 11-1122; Lot Number: 3809856
View official government recall

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