CLASS I ONGOING Device recall · Reported 9 Oct 2024 · FDA Enforcement Report
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV recalled
Percussionaire is recalling Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV, distributed nationwide in the US. The recall was initiated on 21 Aug 2024 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-3207-2024
- FDA event ID
- 95239
- Recalling firm
- Percussionaire, Sandpoint, ID
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 21 Aug 2024
- FDA classified
- 27 Sep 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Aug 2024 | Recall initiated by company | |
| 27 Sep 2024 | Classified by FDA | +37 days |
| 9 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Product as listed by the FDA
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Where it was distributed
US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
Questions about this recall
Why was it recalled?
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Which lots are affected?
No UDI/ Lots: 240620, 240610, 240418, 240326, 230612, WO07066, WO07010, WO06020, WO05019, WO04884, WO04827, WO04756, WO04714, WO04656, WO04625, WO04596, WO04553, WO04398, WO04356, WO04061, WO03846, WO03748, WO03688
Where was it sold?
US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
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.
Other products in this recall event
1 other product · FDA event 95239This product is part of a recall event; the main page for the event is Percussionaire, Inc., REF: P5-Tee-20, Qty: 20, Rx Only. IPV recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Percussionaire, Inc., REF: P5-Tee-20, Qty: 20, Rx Only. IPV recalled | Percussionaire | Other | Nationwide |
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 |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |
| Device | CLASS II | Travel Air, Product Number: S00055 recalled by Percussionaire | Percussionaire | Other | Nationwide |
| Device | CLASS II | Impulsator, Product Number: S00010, Phasitron recalled by Percussionaire | Percussionaire | Other | Nationwide |
| Device | CLASS II | In-Line Valve, Product Number: P5-TEE recalled by Percussionaire | Percussionaire | Other | Nationwide |
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