Spes Medica recalls 10 Fr urethral catheter electrodes due to possible sterilization process deviations. Affected units have reference number UE006 and lot UR20F2702I. No remedy specified in official notice.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Spes Medica is recalling 10 Fr disposable urethral catheter electrodes that may have been improperly sterilized. This could lead to infections or other health risks if used. The recall affects specific model units with reference number UE006 and lot UR20F2702I.
The supplier reported possible deviations in the ethylene oxide sterilization process. This could mean the catheters weren't properly sterilized, increasing infection risk during medical procedures.
Medical professionals and patients using the recalled catheter electrodes are affected. Those with the specific reference number UE006 and lot UR20F2702I are most at risk.
Check for the reference number UE006 and lot number UR20F2702I on the catheter packaging. The product is a 10 Fr disposable urethral catheter electrode with a gold recording/stimulating contact printed on polyurethane film.
Look for reference number UE006 and lot number UR20F2702I on the catheter packaging.
The official recall notice does not specify any remedy or fix for this product.
Check for reference number UE006 and lot number UR20F2702I on the packaging.
The official notice does not specify any action steps for affected units.
We’ve drafted a message you can send Spes Med: 10 Fr Catheter Electrode to request your refund or repair — edit it as you like.
Subject: Recall Z-1968-2021 — Spes Med: 10 Fr Catheter Electrode Spes Med: 10 Fr Catheter Electrode Hello, I own a Spes Med: 10 Fr Catheter Electrode that is covered by recall Z-1968-2021 from Spes Med: 10 Fr Catheter Electrode. 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.
