—#186440

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.

FDA product code: CAF — Nebulizer (Direct Patient Interface)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K961973
Affected lot / code info: Device Model Number: 11-1122; Lot Number: 3809856

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

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.

Timeline

Recall initiated: 2021-03-31
Terminated: 2023-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186440. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.