Quanta System Sterile Optical Laser Fiber Recalled for Potential Sterility Compromise
Quanta System Sterile Optical Laser Fiber units are being recalled because product sterility may be compromised, posing a potential safety risk during medical procedures.
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: FDA Class II recall for potential sterility compromise in a medical device with no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury receive a High (3) rating.
Plain-English summary
Quanta System, S.p.A. is recalling Quanta System Sterile Optical Laser Fiber, single use medical devices because of potential sterility compromise. These devices were distributed nationwide through six U.S. distributors. Approximately 2,427 units are affected across multiple lot numbers and part numbers.
A compromised sterile barrier in medical devices presents a risk of microbial contamination that could affect patient safety during medical procedures.
Persons who have used these devices or healthcare facilities with remaining inventory should contact the manufacturer or their distributor. Healthcare facilities should take appropriate steps to quarantine affected devices and obtain replacement units or further guidance from the manufacturer.
The recalled product
- Product
- Quanta System Sterile Optical Laser Fiber, single use
- Manufacturer
- Quanta System, S.p.A.
- Affected units
- 2,427
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 (20)
- Product Part Numbers: OAF002011 - lots A194207
- A194208
- A194528
- A194529
- A201001
- A201002 OAF005511 - lots A184635
- A192114
- A193613
- A194527
- A384633
- A392907 OAF702711 - lots A190301
- A192113
- A192906
- A193110
- A193111
- A193112
- A194108
- A194211
- A194532 OAF703611 - lots A180300
- A190302
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Quanta System, S.p.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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