FDA recall Z-0290-2024

Product

Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)

Reason for recall

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2023-10-12

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0290-2024