Quanta System Sterile Optical Laser Fiber recall: Sterility Concern
Quanta System Sterile Optical Laser Fiber, single use
Why was Quanta System Sterile Optical Laser Fiber recalled?
Product sterility is potentially compromised.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Product Part Numbers: OAF002011 - lots A194207, A194208, A194528, A194529, A201001, A201002 OAF005511 - lots A184635, A192114, A193613, A194527, A202027 OAF006001 - lots A183626 and A193106 OAF008001 - lot A193616 OAF009901 - lot A192911 and A193108 OAF009911 - lots A192914 and A202028 OAF302711 - 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
- Product
- Quanta System Sterile Optical Laser Fiber, single use
- Recalling firm
- Quanta System, S.p.A.
- Quantity
- 2427 units
- Distribution
- Nationwide distribution via 6 US distributors
- Recall date
- June 16, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)