Spes Medica recalls SNS Disposable Urethral Catheter Electrodes due to possible sterilization process deviations. This may affect safety during medical procedures.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Spes Medica is recalling certain disposable urethral catheter electrodes because the sterilization process might not have been done correctly. This could lead to safety issues during medical procedures.
The supplier reported possible deviations in the ethylene oxide sterilization process. This could mean the catheters are not properly sterilized, increasing infection risk during medical procedures.
Patients and healthcare providers who use the recalled catheter electrodes. Those most at risk are individuals receiving medical procedures requiring these electrodes.
The product is labeled as 'SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film'. Lot number UR20F2699I is associated with this recall.
Look for the lot number UR20F2699I on the catheter electrode packaging.
The supplier informed Spes Medica of possible deviations in the ethylene oxide sterilization process.
Check the product label for the lot number UR20F2699I. If it matches, contact Spes Medica for instructions.
The recall indicates a possible sterilization issue, so it is not safe to use without confirmation from Spes Medica.
We’ve drafted a message you can send Spes Med: A medical device company to request your refund or repair — edit it as you like.
Subject: Recall Z-1970-2021 — Spes Med: A medical device company Spes Med: A medical device company Hello, I own a Spes Med: A medical device company that is covered by recall Z-1970-2021 from Spes Med: A medical device company. 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.
