Z-0693-2024Class I

Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)

Name: Z-0693-2024 Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Creator: Percussionaire Corporation
Published: 2023-03-28
License: https://open.fda.gov/license/

Percussionaire Corp. / initiated 2023-03-28 / Open, Classified / root cause: manufacturing process

FDA source

Percussionaire Corporation began a recall of Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) on 2023-03-28. FDA classified it as Class I and gives the reason as "Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy". 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-0693-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-03-28
Posted: 2024-01-17
Recalling firm: Percussionaire Corp.
Product: Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 3/28/23, correction notices were emailed to customers who were asked to remove and switch the reservoir bag to the proper location. On 1/24/24, follow-up correction notices were sent to customers who were asked to do the following: 1) Review your inventory, and if affected devices are identified, ensure the reservoir bag is in the proper location. 2) If affected devices were further distributed, send a copy of this notice to your customers. 3) Complete and return the Effectiveness Check Questionnaire via email to [email protected] If you have any questions, contact the firm's Customer Service at [email protected] or by phone at (208)- 263- 2549 Monday - Friday from 7 AM to 3:30 PM (PST). Additional information for contact information can be found at www.sentec.com/contact
Quantity in commerce: 195
Distribution: US: RI, CA, TX
Product codes and lots: UDI-DI: 00849436000693, Lots/Expiration: WO03739/September 13, 2024, and WO04218/November 14, 2024.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0693-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0693-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17

Product code CBK

K905235Class IIVdr Sinusoidal Percusionator Family/relate AccessPercussionaire Corp. / cleared 1991-05-03

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)