CLASS I ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
High Frequency Transport Phasitron Breathing Circuit Kit recalled
Percussionaire is recalling High Frequency Transport Phasitron Breathing Circuit Kit, distributed in 18 states. The recall was initiated on 12 Dec 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0637-2024
- FDA event ID
- 93476
- Recalling firm
- Percussionaire, Sandpoint, ID
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Dec 2023
- FDA classified
- 17 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Dec 2023 | Recall initiated by company | |
| 17 Jan 2024 | Classified by FDA | +36 days |
| 24 Jan 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Where it was distributed
US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None
AlabamaArkansasCaliforniaConnecticutFloridaGeorgiaIllinoisKansasLouisianaMichiganMinnesotaMissouriNorth CarolinaNew JerseyTennesseeTexasUtahVirginia
Questions about this recall
Why was it recalled?
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
Which lots are affected?
UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028
Where was it sold?
US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Percussionaire
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
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