Recall Z-0693-2024— Percussionaire Corporation

Name: FDA recall Z-0693-2024
Creator: U.S. Food and Drug Administration
Published: 2023-03-28

Class I · Ongoing

Class I FDA medical device recall by Percussionaire Corporation, initiated 2023-03-28. It names one FDA 510(k) clearance: K905235. Product: Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit). Reason: Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy..

Recalling firm: Percussionaire Corporation
Classification: Class I
Status: Ongoing
Initiated: 2023-03-28
Firm location: Sandpoint, ID, United States

510(k) clearances named in this recall

1 on FDA's record

K905235 — VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESSPercussionaire Corp.·cleared 1991-05-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.

Data sourced from openFDA. This site is unofficial and independent of the FDA.