Vasoshield Syringe Packs recall: Foreign Material
Vasoshield Syringe Packs, Model VH-5001
Why was Vasoshield Syringe Packs 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00607567700468; Serial Numbers: 25147126, 25151632, 25152389, 25152964, 25163138, 25162077
- Product
- Vasoshield Syringe Packs, Model VH-5001
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 530 units US, 215 units OUS
- Distribution
- US Nationwide. Japan, Germany.
- Recall date
- January 25, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)