Reported Jan 25, 2023 · Ongoing
Hemopro 2 with Vasoshield, Model VH-4001
Maquet Cardiovascular, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
Hemopro 2 with VasoshieldModel VH-4001
- Lot codes and dates
- UDI-DI00607567700901
- Serial Numbers
251521072515220425152293251524632515277125153153251532732515336625153585251538472515396025154066251548802515526225155326251557852515624525156642251570162515708525157244251577002515789825158066251581522515837425158822251589652515910025159335251595722515969525159791251602552516039825160498251607122516096125161193251614232516167225162202251624072516250525163168251632812516336730002369283000251969
- Amount recalled
- 9817 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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