FDA recall Z-1189-2023

Product

BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.

Reason for recall

Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.

Distribution

US Nationwide distribution in the state of Oklahoma.

Key facts

Status

Terminated

Initiation date

2023-02-03

Report date

2023-03-22

Termination date

2024-09-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1189-2023