CooperSurgical recalls 10mm x 10mm Square Wallach Loop Electrodes (P/N 909131) that were incorrectly packaged with round electrodes. This packaging error may lead to incorrect use during medical procedures.
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
CooperSurgical is recalling 10mm x 10mm Square Wallach Loop Electrodes (P/N 909131) that were mistakenly packaged with round electrodes inside square packages. This error could cause incorrect use during medical procedures if the wrong electrode type is used.
The electrodes were incorrectly packaged with a round electrode inside a package labeled as square. This could lead to using the wrong electrode type during medical procedures, potentially causing incorrect treatment outcomes.
Medical professionals using these electrodes for procedures like electro-excision or electro-fulguration of the lower genital tract are affected. Patients receiving these procedures may be at risk if the wrong electrode is used.
Check for the product name 'Wallach Loop Electrode 10mm x 10mm Square' with part number 909131. The affected items were sold with lot number 274420.
Verify the electrode shape and part number on the packaging to ensure it matches the label.
The affected Wallach LOOP Electrodes were incorrectly packaged with a round electrode inside a package labeled as a square electrode.
The official recall notice does not specify a remedy or action steps for affected items.
The recall indicates a packaging error that could lead to incorrect use, but the product itself is not unsafe if used correctly.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1847-2021 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-1847-2021 from CooperSurgical. 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.
