FDA recall Z-0995-2023

Product

Hemopro 2 with Vasoshield, Model VH-4001

Reason for recall

Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.

Distribution

US Nationwide. Japan, Germany.

Key facts

Status

Ongoing

Initiation date

2022-12-22

Report date

2023-01-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0995-2023