Quanta System Sterile Optical Laser Fiber Recall for Potential Sterility Compromise
Quanta System is recalling 307 reusable sterile optical laser fibers nationwide due to potential sterility compromise. The affected devices were distributed through six U.S. distributors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is potential sterility compromise, representing a risk-of-harm scenario where injury has not yet been reported, consistent with the 'High' severity classification.
Plain-English summary
Quanta System, S.p.A. is recalling Quanta System Sterile Optical Laser Fiber, reusable devices. The recall affects 307 units distributed nationwide through six U.S. distributors. Specific part numbers and lot codes are listed in the FDA recall notice.
The recall is due to potential compromise of product sterility. In medical devices, compromised sterility can pose a risk to patients if the devices are used clinically.
Affected healthcare facilities and medical professionals are advised to consult the FDA recall notice for detailed information and any instructions from the manufacturer.
The recalled product
- Product
- Quanta System Sterile Optical Laser Fiber, reusable
- Manufacturer
- Quanta System, S.p.A.
- Hazard
- sterility-compromise
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Product Part Numbers: OAF002013 Lots A201003 OAF005513 Lots A184636
- A192118
- A193101 OAF006003 Lot A195008 OAF008003 Lots A193615
- A194021 OAF008013 Lots A183623
- A192119 OAF009903 Lots A193109
- A193617 OAF009913 Lots A181350
- A192910 OAF702713 Lots A182415
- A193104
- A194109
- A194723 OAF703613 Lot A180150
Distribution
Distributed nationwide across the United States.
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