Quanta System recalls sterile optical laser fibers due to potential sterility compromise. Affected units have specific part numbers and lots. Consumers should contact the manufacturer for details.
Product sterility is potentially compromised.
Quanta System is recalling reusable sterile optical laser fibers because the product's sterility might be compromised. This could lead to infections if the fibers are used in medical procedures without proper sterility.
The fibers may not maintain sterility properly, which could lead to infections during medical procedures. This risk is due to potential contamination from the manufacturing process.
Medical professionals using the fibers for procedures are most at risk. The recall affects specific models and production lots.
Check for part numbers OAF002013, OAF005513, OAF006003, OAF008003, OAF008013, OAF009903, OAF009913, or OAF702713 with listed lots. The product was sold with specific production dates and lots.
Identify the part number and lot number on the product label to confirm if it is affected.
The product sterility is potentially compromised, which could lead to infections if used in medical procedures.
The recall does not specify a remedy, so contact Quanta System directly for instructions.
Affected models include OAF002013, OAF005513, OAF006003, OAF008003, OAF008013, OAF009903, OAF009913, and OAF702713 with specific lots.
We’ve drafted a message you can send Quanta System to request your refund or repair — edit it as you like.
Subject: Recall Z-1844-2021 — Quanta System Quanta System Hello, I own a Quanta System that is covered by recall Z-1844-2021 from Quanta System. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
