FDA Enforcement
Class II
Ongoing
Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
Recall: Z-0221-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0221-2024
- Event ID
- 93188
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Securitas Healthcare LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- September 25, 2023
- Classification Date
- November 3, 2023
- Address
- 4600 Vine St, Lincoln, NE, 68503-2823, United States
Description
Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
Reason
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Code Info
Manufacturing date codes: 23128 to 23251
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Quantity
2691 units