Recall Z-1516-2021 ยท CAF Nebulizer (Direct Patient Interface)
Smiths Medical ASD Inc.
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.
| Date | Mar 31, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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 Fi |
| Quantity | 250 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961973 | DHD ACE WITH MASK KIT Dhd Diemolding Healthcare Div., Aug 15, 1996 |