FDA recall Z-2248-2023

Product

Carina Sub-Acute Care Ventilator

Reason for recall

Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

Distribution

US Nationwide Distribution.

Key facts

Status

Ongoing

Initiation date

2023-07-12

Report date

2023-08-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2248-2023