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.

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.

A Recall notification letter titled, "URGENT MEDICAL DEVICE FIELD SAFETY NOTICE" was sent to consignees beginning on 03/31/2021 via email. Consignees were notified to follow the instructions listed in the Recall Notice. Consignees were instructed to identify any affected devices in their possession (listed in the Recall Notice). If consignees have affected devices in their possession, the notice instructs them to inspect devices to determine if the device label matches the shipping box labels. The consignees should complete the response form and return to Smiths Medical. After the completed Field Safety Response Form has been submitted to [email protected], the consignee will be contacted to arrange for return of any affected product. Distributors were instructed in the notice to immediately notify their customers who may have received affected devices of the Recall and provide them a copy of Recall Notice and the accompanying Response Form.