CLASS I ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
Distal Phasitron, Part: S20020, for use recalled by Percussionaire
Percussionaire is recalling Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or, distributed in California, Rhode Island, Texas. The recall was initiated on 28 Mar 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-0693-2024
- FDA event ID
- 93648
- Recalling firm
- Percussionaire, Sandpoint, ID
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 28 Mar 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
| 28 Mar 2023 | Recall initiated by company | |
| 17 Jan 2024 | Classified by FDA | +295 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
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
Product as listed by the FDA
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Where it was distributed
US: RI, CA, TX
Questions about this recall
Is Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or recalled?
Yes. Percussionaire recalled Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or on 28 Mar 2023. The recall is Class I and its status is Ongoing. Recall number Z-0693-2024.
Why was it recalled?
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
Which lots are affected?
UDI-DI: 00849436000693, Lots/Expiration: WO03739/September 13, 2024, and WO04218/November 14, 2024.
Where was it sold?
US: RI, CA, TX
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 21 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 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Phasitron 5, IPV In-Line Valve recalled by Percussionaire | Percussionaire | Packaging Defects | Nationwide |
| Device | CLASS I | VDR4 Phasitron Breathing Circuit recalled by Percussionaire | Percussionaire | Other | Nationwide |
| Device | CLASS I | Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10) recalled | Percussionaire | Other | 40 states |
| Device | CLASS I | Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV recalled | Percussionaire | Other | Nationwide |
| Device | CLASS I | Percussionaire, Inc., REF: P5-Tee-20, Qty: 20, Rx Only. IPV recalled | Percussionaire | Other | Nationwide |
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