Maquet Cardiovascular, LLC: Vasoshield Syringe Packs, Model VH-5001

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.

Details from the source

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. Quantity: 530 units US, 215 units OUS Lot/code info: UDI-DI: 00607567700468; Serial Numbers: 25147126, 25151632, 25152389, 25152964, 25163138, 25162077

UPC codes

00607567700468

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.