Quanta System recalls sterile optical laser fibers with specific part numbers due to potential sterility compromise. Affected units may pose infection risks if used in medical procedures.
Product sterility is potentially compromised.
Quanta System is recalling sterile optical laser fibers that could have compromised sterility, meaning they might not be clean enough for medical use. This could lead to infections if used in procedures requiring sterile conditions.
The fibers may not be sterile as intended, which could lead to infections during medical procedures. This happens because the sterility is potentially compromised during manufacturing or handling.
Medical professionals using these fibers for procedures may be affected. Patients undergoing surgery with compromised sterility could face infection risks.
Check for part numbers OAF002011 through OAF703611 with specific lots listed in the recall notice. These fibers were sold with the listed part numbers and lots.
Identify the part number and lot numbers listed in the recall notice to confirm if your product is affected.
The recall is due to potential sterility compromise, which could lead to infections if used in medical procedures.
Check the part number and lot numbers against the list provided in the recall notice to see if your product is affected.
The recall notice does not specify a remedy, so no action is required beyond checking if your product is affected.
We’ve drafted a message you can send Quanta System to request your refund or repair — edit it as you like.
Subject: Recall Z-1843-2021 — Quanta System Quanta System Hello, I own a Quanta System that is covered by recall Z-1843-2021 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.
