FDA recall Z-1272-2023

Product

Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW

Reason for recall

There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.

Distribution

Worldwide distribution - US Nationwide and the country of UK.

Key facts

Status

Ongoing

Initiation date

2022-12-16

Report date

2023-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Exeter, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1272-2023