FDA Medical Device Recalls (openFDA)
Percussionaire Corporation: Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
- Recall number
- Z-3207-2024
- Recalling firm
- Percussionaire Corporation
- Product
- Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
- Status
- Open, Classified
- Initiated
- 2024-08-21
- Posted
- 2024-09-27
- Terminated
- not on file
- Reason
- Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
- 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 regulatory.percussionaire@sentec.com 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 FSCA@sentec.com.
- Quantity
- 50,460 units
- Distribution
- US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BZO
- Firm FEI
- 1000524541
- Firm city
- Sandpoint
- Firm state
- ID
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28