Recall Z-0637-2024— Percussionaire Corporation

Name: FDA recall Z-0637-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-12

Class I · Ongoing

Class I FDA medical device recall by Percussionaire Corporation, initiated 2023-12-12. It names one FDA 510(k) clearance: K905234. Product: High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123. 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.

Recalling firm: Percussionaire Corporation
Classification: Class I
Status: Ongoing
Initiated: 2023-12-12
Firm location: Sandpoint, ID, United States

510(k) clearances named in this recall

1 on FDA's record

K905234 — TXP TRANSPORTER FAMILY AND RELATED ACCESSORIESPercussionaire Corp.·cleared 1991-06-13

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

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

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

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