FDA-Device2023-01-25Class II
Hemopro 2 with Vasoshield, Model VH-4001
Maquet Cardiovascular, LLC
Hazard
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.
Sold states
US Nationwide. Japan, Germany.
Affected count
9817 devices
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Hemopro 2 with Vasoshield, Model VH-4001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0995-2023Don't want to check this manually?
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