Vasoshield Syringe Packs, Model VH-5001
Reported: January 25, 2023 Initiated: December 22, 2022 #Z-0996-2023
Product Description
Vasoshield Syringe Packs, Model VH-5001
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.
Details
- Recalling Firm
- Maquet Cardiovascular, LLC
- Units Affected
- 530 units US, 215 units OUS
- Distribution
- US Nationwide. Japan, Germany.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Vasoshield Syringe Packs, Model VH-5001. Recalled by Maquet Cardiovascular, LLC. Units affected: 530 units US, 215 units OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2023. Severity: Moderate. Recall number: Z-0996-2023.
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