FDA recall Z-3207-2024

Product

Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

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.

Distribution

US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey

Key facts

Status

Ongoing

Initiation date

2024-08-21

Report date

2024-10-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sandpoint, ID, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3207-2024