FDA recall Z-0637-2024

Product

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

Distribution

US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None

Key facts

Status

Ongoing

Initiation date

2023-12-12

Report date

2024-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sandpoint, ID, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0637-2024