FDA Medical Device Recalls (openFDA)
Percussionaire Corporation: High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
- Recall number
- Z-0637-2024
- Recalling firm
- Percussionaire Corporation
- Product
- High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
- Status
- Open, Classified
- Initiated
- 2023-12-12
- Posted
- 2024-01-17
- Terminated
- not on file
- Reason
- Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
- Root cause
- Process control
- Action
- On January 17, 2024, Percussionaire issued a Urgent Medical Device Recall Notification Update via E-Mail to affected consignees to provide additional information. The original notification was issued on December 12, 2023. Percussionaire asked consignees to take the following actions: Customer Instructions 1. Complete and Return Acknowledgement form (attached). 2. Complete Pre-Check Checklist prior to patient use. 3. Prioritize the return of all impacted product. 4. Report any adverse reactions or quality problems experienced with the use of this product to Percussionaire/Sentec Customer Service department via email (customerservice.us@sentec.com) or FDA s MedWatch Adverse Event reporting program either online or by regular mail or fax. Distributor Instructions 1. Complete and Return Distributor Acknowledgement form (attached). 2. Send Urgent Field Safety Notice containing Pre-Use Checklist to end customers. 3. Prioritize the return of affected lots in stock. 4. Support end customers returning affected products. 5. Report any adverse reactions or quality problems experienced with the use of this product to Percussionaire/Sentec Customer Service department via email (customerservice.us@sentec.com) or FDA s MedWatch Adverse Event reporting program either online or by regular mail or fax.
- Quantity
- 2145 units
- Distribution
- US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None
- Lot, serial or model codes
- UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028
- 510(k) numbers
- ["K905234"]
- PMA numbers
- not on file
- Product code
- CBK
- 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