Percussionaire IPV In-Line Valve Recall: Blue Cap Removal Labeling Update
Percussionaire is recalling the P5-TEE IPV in-line valve to update labeling and ensure the blue cap is removed before use and delivery of the device.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class I medical device recall. Per the severity rubric, FDA Class I recalls require a minimum severity score of 4. While no illnesses or injuries have been reported, the Class I designation indicates a reasonable probability of serious adverse health consequences if the hazard is not addressed.
Plain-English summary
The Percussionaire P5-TEE IPV (Intrapulmonary Percussive Ventilation) in-line valve is being recalled. Approximately 50,460 units distributed nationwide in the United States and internationally are affected.
Updated labeling is required to ensure that the blue cap on the in-line valve is properly removed prior to delivery of the device for use in IPV therapy.
The recall affects devices distributed nationwide in the United States, as well as in Israel, Japan, Russia, Switzerland, Canada, and Turkey. Multiple affected lot numbers have been identified, including lots 240620, 240610, 240418, 240326, and others.
If you have one of the affected devices, consult the updated labeling and verify that the blue cap has been removed. Contact Percussionaire Corporation for additional information or instructions regarding your device.
The recalled product
- Product
- Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
- Manufacturer
- Percussionaire Corporation
- Affected units
- 50,460
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 (20)
- No UDI/ Lots: 240620
- 240610
- 240418
- 240326
- 230612
- WO07066
- WO07010
- WO06020
- WO05019
- WO04884
- WO04827
- WO04756
- WO04714
- WO04656
- WO04625
- WO04596
- WO04553
- WO04398
- WO04356
- WO04061
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Percussionaire Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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