Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm
Summary
The FDA issued a Class II for Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362 by Securitas Healthcare LLC. Reason: Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System..
Details
Source
Device Recall
External ID
Z-0222-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm
Lot/Code Info: Manufacturing date codes: 23128 to 23251
Quantity Affected: 49 devices
Reason for Recall
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-25
Company
Lincoln, NE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Securitas Healthcare LLC has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Securitas Healthcare LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Securitas Healthcare LLC have FDA actions?
Securitas Healthcare LLC has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0222-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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