FDA recall Z-2592-2021

Product

Atrium Pneumostat Chest Drain Valve, Part Number 16100

Reason for recall

The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Key facts

Status

Ongoing

Initiation date

2021-08-26

Report date

2021-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2592-2021