Qura recalls Spectrum Medical Quantum Standard heat exchangers with specific batch numbers due to potential inadequate sterilization and lack of US 510(k) clearance.
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
Qura is recalling certain Spectrum Medical Quantum Standard heat exchangers because they may not have been properly sterilized and are not approved for use in the US. This could lead to infection risks if used without proper sterilization.
The heat exchangers may not have been adequately sterilized, which could lead to infection if used in medical procedures. Additionally, these devices are not approved for use in the US under FDA regulations.
Medical professionals and facilities using the recalled heat exchangers with batch numbers B000129, C000415, C000416, or C000417 are most at risk.
Check the batch number on the heat exchanger. The recalled units have batch numbers B000129, C000415, C000416, or C000417.
Identify the batch number on the heat exchanger to determine if it is recalled.
The recall indicates potential inadequate sterilization and lack of US approval, so they are not safe for use without verification.
Check the batch number to see if it is one of the recalled batches (B000129, C000415, C000416, C000417).
The recall does not mention any repair options; the remedy is not specified.
We’ve drafted a message you can send Qura to request your refund or repair — edit it as you like.
Subject: Recall Z-2277-2021 — Qura Qura Hello, I own a Qura that is covered by recall Z-2277-2021 from Qura. 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.
