Percussionaire Corporation: Device Recall

Recall Details

Recall Number

Z-3208-2024

Classification

Class I

Product Type

Device

Recalling Firm

Percussionaire Corporation

Status

Ongoing

Date Initiated

08/21/2024

Location

Sandpoint, ID, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2523 units

Reason for Recall

Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

Product Description

Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

Distribution Pattern

US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey

Other Recalls by Percussionaire Corporation

• Class I: Dangerous 09/17/2025
  IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
• Class I: Dangerous 12/23/2024
  Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
• Class I: Dangerous 09/16/2024
  As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.
• Class I: Dangerous 08/21/2024
  Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

View all recalls by Percussionaire Corporation →