FDA recall Z-1445-2023

Product

VentStar breathing bag Set (P) 110, MP00384

Reason for recall

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Distribution

Domestic: US Nationwide Distribution.

Key facts

Status

Terminated

Initiation date

2023-04-17

Report date

2023-05-24

Termination date

2024-09-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1445-2023