Summary
The FDA issued a Class I for Sara Plus Active Floor Lift by ARJOHUNTLEIGH POLSKA Sp. z.o.o.. Reason: The device may emit smoke or ignite..
Details
Source
Device Recall
External ID
Z-1098-2022
Action Date
2022-06-01
Status
Terminated
Category
device
Product Description
Sara Plus Active Floor Lift
Lot/Code Info: Model Numbers: HEP0001, HEP0001-AU, HEP0001-BR, HEP0001-CN, HEP0001-JP, HEP0001-UK, HEP0001-US, HEP1001, HEP1001-AU, HEP1001CON4869, HEP1001-US, HEP2001, HEP2001-BR, HEP2001-CN, HEP2001-UK
Quantity Affected: 4449 devices
Reason for Recall
The device may emit smoke or ignite.
Distribution
US Nationwide and Worldwide distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-05
Company
Komorniki
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ARJOHUNTLEIGH POLSKA Sp. z.o.o. has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (ARJOHUNTLEIGH POLSKA Sp. z.o.o.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ARJOHUNTLEIGH POLSKA Sp. z.o.o. have FDA actions?
ARJOHUNTLEIGH POLSKA Sp. z.o.o. 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-1098-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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