Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
Summary
The FDA issued a Class II for Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840 by Western/Scott Fetzer Company. Reason: VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke.
Details
Source
Device Recall
External ID
Z-0267-2022
Action Date
2021-12-01
Status
Ongoing
Category
device
Product Description
Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
Lot/Code Info: Units distributed from 05/29/20 to 08/31/21. Digital VIPR units manufactured and distributed after 08/31/21 are outside the scope of this recall and will be recognized by a green and silver control knob sticker (green logo, silver background)
Quantity Affected: 11341 units
Reason for Recall
VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
Distribution
CT, MD, MT, OH
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-16
Company
Westlake, 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 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Western/Scott Fetzer Company has 5 FDA actions in our database, including 5 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 (Western/Scott Fetzer Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Western/Scott Fetzer Company have FDA actions?
Western/Scott Fetzer Company has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0267-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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