High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Summary
The FDA issued a Class I for High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, by Percussionaire Corporation. Reason: Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to t.
Details
Source
Device Recall
External ID
Z-0637-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Lot/Code Info: UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028
Quantity Affected: 2145 units
Reason for Recall
Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
Distribution
US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-12
Company
Sandpoint, ID
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 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Percussionaire Corporation has 8 FDA actions in our database, including 8 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 (Percussionaire Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Percussionaire Corporation have FDA actions?
Percussionaire Corporation has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0637-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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