Summary
The FDA issued a Class III for Pneupac paraPac plus 300 ventilator kit, REF P300NGB by Smiths Medical ASD Inc.. Reason: Two devices were labeled with the same serial number.
Details
Source
Device Recall
External ID
Z-0163-2022
Action Date
2021-11-03
Status
Terminated
Category
device
Product Description
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Lot/Code Info: SN RF70121
Quantity Affected: 2 units
Reason for Recall
Two devices were labeled with the same serial number
Distribution
UK
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-15
Company
Minneapolis, MN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 124 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Smiths Medical ASD Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smiths Medical ASD Inc. have FDA actions?
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0163-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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