Percussionaire Distal Phasitron respiratory device with reservoir bag assembly defect recalled
Percussionaire Corporation recalled 195 Distal Phasitron devices after finding the breathing circuit reservoir bag may be assembled at the wrong attachment point, potentially affecting therapy delivery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I classifications establish a minimum severity score of 4. No deaths or serious injuries have been reported in the source text, but the Class I designation indicates a reasonable probability of serious adverse health consequences.
Plain-English summary
Percussionaire Corporation is recalling the Distal Phasitron (Part S20020), a respiratory therapy device designed to work with the Percussionaire VDR-4 control driver. A total of 195 units have been identified in the recall. The device is distributed in Rhode Island, California, and Texas.
The Distal Phasitron may have been assembled with the breathing circuit reservoir bag attached at the wrong attachment point. This defect can result in less than optimal therapy delivery, potentially compromising the effectiveness of respiratory treatment.
Patients and healthcare providers who have received this device should verify the lot numbers (WO03739 with expiration date September 13, 2024, and WO04218 with expiration date November 14, 2024) and contact Percussionaire Corporation if they have affected units.
The recalled product
- Product
- Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
- Manufacturer
- Percussionaire Corporation
- Hazard
- assembly-defect
- therapy-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 00849436000693
- Lots/Expiration: WO03739/September 13
- 2024
- and WO04218/November 14
- 2024.
Distribution
Distributed in 3 states:
- CA
- RI
- TX
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