FDA recall Z-1954-2018

Product

Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.

Reason for recall

The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.

Distribution

Distributed to the states of CT, IL, MN, NV, SD, and WA.

Key facts

Status

Terminated

Initiation date

2018-04-26

Report date

2018-06-06

Termination date

2018-09-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1954-2018