Z-0637-2024Class I

High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

Name: Z-0637-2024 High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Creator: Percussionaire Corporation
Published: 2023-12-12
License: https://open.fda.gov/license/

Percussionaire Corp. / initiated 2023-12-12 / Open, Classified / root cause: manufacturing process

FDA source

Percussionaire Corporation began a recall of High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 on 2023-12-12. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0637-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-12
Posted: 2024-01-17
Recalling firm: Percussionaire Corp.
Product: High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: 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 tag: manufacturing process
FDA 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 ([email protected]) 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 ([email protected]) or FDA s MedWatch Adverse Event reporting program either online or by regular mail or fax.
Quantity in commerce: 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
Product codes and lots: UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0637-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0637-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17

Product code CBK

K905234Class IITxp Transporter Family and Related AccessoriesPercussionaire Corp. / cleared 1991-06-13

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)