Class 2 Device Recall ACE MDI Spacer with Small Mask

• Date Initiated by Firm: March 31, 2021
• Create Date: April 29, 2021
• Recall Status: Terminated on January 31, 2023
• Recall Number: Z-1516-2021
• Recall Event ID: 87642
• 510(K)Number: K961973
• Product Classification: Nebulizer (direct patient interface) - Product Code CAF
• 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.
• Code Information: Device Model Number: 11-1122; Lot Number: 3809856
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: Dave Halverson; 763-383-3310
• Manufacturer 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.
• FDA Determined 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 Field Safety Response Form has been submitted to fieldactions@smiths-medical.com, 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CAF