Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provi
Summary
The FDA issued a Class I for Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmona by Percussionaire Corporation. Reason: As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific me.
Details
Source
Device Recall
External ID
Z-0208-2025
Action Date
2024-11-06
Status
Ongoing
Category
device
Product Description
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Lot/Code Info: Model Numbers: P5-10 P5-HC P5-UC-10 UDI-DI codes: Lot Numbers: 240321 240329 240412 240430 240509 240516 240614 240625 240627
Quantity Affected: 43,830 devices
Reason for Recall
As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.
Distribution
U.S.: PA, AR, MI, CA, TX, OH, NY, FL, IL, NE, OR, GA, WI, MO, OK, AL, WV, MT, CO, LA, VA, CT, SC, NH, NV, NC, NJ, MI, UT, ID, ME, MN, SD, ID, ND, KS, KY, TN, MD, VT, MA, RI, O.U.S.: Canada, Switzerland (all products shipped OUS remained in Sentec AG's (distributor, parent company of Percussionaire) control, were quarantined, and did not leave the warehouse).
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-16
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 243 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-0208-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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