Hemopro 2 with Vasoshield, Model VH-4001
FDA Recall #Z-0995-2023 — Class II — December 22, 2022
Product Description
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.
Recalling Firm
Maquet Cardiovascular, LLC — Wayne, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9817 devices
Distribution
US Nationwide. Japan, Germany.
Code Information
UDI-DI: 00607567700901; Serial Numbers: 25152107, 25152204, 25152293, 25152463, 25152771, 25153153, 25153273, 25153366, 25153585, 25153847, 25153960, 25154066, 25154880, 25155262, 25155326, 25155785, 25156245, 25156642, 25157016, 25157085, 25157244, 25157700, 25157898, 25158066, 25158152, 25158374, 25158822, 25158965, 25159100, 25159335, 25159572, 25159695, 25159791, 25160255, 25160398, 25160498, 25160712, 25160961, 25161193, 25161423, 25161672, 25162202, 25162407, 25162505, 25163168, 25163281, 25163367, 3000236928, 3000251969
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated