Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.
Recall
- Recall Number
- Z-1515-2021
- Event Number
- 87642
- Firm
- Smiths Medical ASD Inc.
- FEI Number
- 3012307300
- Product Code
- BYI
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 31, 2021
- Terminated
- January 31, 2023
- Address
- 6000 Nathan Ln N, Minneapolis, MN, 55442-1690
Description
Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.
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.
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.
682 units