Reported Jun 16, 2021 · Terminated
Quanta System Sterile Optical Laser Fiber, single use
Quanta System, S.p.A.
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: Quanta System, S.p.A. · Via Acquedotto 109 · Samarate, N/A · N/A
Is this the product you have?
- Quanta System Sterile Optical Laser Fiber, single use
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 lot A193616 OAF009901 2 lot A192911 and A193108 OAF009911 - lots A192914 and A202028 OAF302711 3 lot A202029 OAF402011 - lots A380350, A384633, A392907 OAF702711 - lots A190301, A192113, A192906, A193110, A193111, A193112, A194108, A194211, A194532 OAF703611 - lots A180300, A190302, A190303, A192115, A192908, A193102, A193113, A194209, A194210, A195013, A195014 - Amount recalled
- 2427 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Product sterility is potentially compromised.
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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