Z-3207-2024Class I

Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy...

Name: Z-3207-2024 Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy...
Creator: Percussionaire Corporation
Published: 2024-08-21
License: https://open.fda.gov/license/

Percussionaire Corp. / initiated 2024-08-21 / Open, Classified / root cause: design

FDA source

Percussionaire Corporation began a recall of Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve on 2024-08-21. FDA classified it as Class I and gives the reason as "Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-3207-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-08-21
Posted: 2024-09-27
Recalling firm: Percussionaire Corp.
Product: Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Product code: BZO Set, Tubing And Support, Ventilator (W Harness)
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.
Root cause tag: design
FDA root cause: Device Design
Action: On September 3, 2024, Percussionaire Inc. issued a "Urgent Medical Device Field Safety Notice" to affected consignees. Percussionaire asked consignees to take the following actions: 1. Complete and Return Acknowledgement form (see Appendix 1) after reviewing and implementing the requested actions below by September 27, 2024. 2. Review updated instructions for proper in-line use (see Appendix 3) and updated IFU (see Appendix 4) 3. Print and post updated instructions for proper In-Line Valve use (Appendix 3) throughout your facility for adequate distribution of new information to users. 4. Communicate and train with newly presented instructions for proper use to primary users of IPV therapy, specifically for in-line use. 5. Review institutional protocols related to P5-TEE inline use and update as needed to conform with the updated instructions. 6. Re-label current product by placing the sticker provided by Percussionaire on each individual P5-TEE bag on stock (stickers to be provided via mail). 7. Report any adverse events to [email protected] and/or to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 8. Report any quality problems experienced with the use of this product to Percussionaire/Sentec Customer Service department via email to [email protected].
Quantity in commerce: 50,460 units
Distribution: US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3207-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3207-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-09-27
Z-3208-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-09-27

Product code BZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)