Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging bri
Summary
The FDA issued a Class II for Affected components are limited to the Monoprice charging cable (Product # 4867) by Forbes Rehab Services Inc. Reason: Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Gen.
Details
Source
Device Recall
External ID
Z-0423-2022
Action Date
2022-01-05
Status
Ongoing
Category
device
Product Description
Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)
Lot/Code Info: All units
Quantity Affected: 3065 units
Reason for Recall
Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-11
Company
Mansfield, OH
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 90 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Forbes Rehab Services Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Forbes Rehab Services Inc have FDA actions?
This is the only FDA action we have on record for Forbes Rehab Services Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0423-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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