FDA recall Z-1659-2023

Product

QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829

Reason for recall

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

Distribution

Nationwide domestic distribution

Key facts

Status

Ongoing

Initiation date

2023-05-18

Report date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1659-2023