Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patien
Summary
The FDA issued a Class II for Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be us by Arjohuntleigh Magog, Inc.. Reason: Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach..
Details
Source
Device Recall
External ID
Z-1629-2023
Action Date
2023-05-31
Status
Ongoing
Category
device
Product Description
Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment
Lot/Code Info: UDI/DI 05055982760713, Serial Numbers: 300501841, 300501842, 300515661
Quantity Affected: 3
Reason for Recall
Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach.
Distribution
US: OH, NY
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-17
Company
Magog, N/A
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 141 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Arjohuntleigh Magog, Inc. has 2 FDA actions in our database, including 2 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 (Arjohuntleigh Magog, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Arjohuntleigh Magog, Inc. have FDA actions?
Arjohuntleigh Magog, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1629-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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