Z-1516-2021 Class II Terminated
FDA device recall Z-1516-2021 was initiated by Smiths Medical ASD Inc. on March 31, 2021 and is designated Class II. 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. The recall status is terminated (terminated January 31, 2023). Affected quantity: 250 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- March 31, 2021
- Termination Date
- January 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250 units
Product Description
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 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.
Code Information
Device Model Number: 11-1122; Lot Number: 3809856