CooperSurgical recalls Koh Cup 3.5cm model (P/N 34131-04) due to incorrect packaging. This model is not the required 3.0cm size and may cause improper use during vaginal procedures.
The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
CooperSurgical is recalling a specific 3.5cm Koh Cup model because it was incorrectly packaged instead of the required 3.0cm size. Using this model could lead to improper vaginal procedure delineation.
The Koh Cup is designed to be a vaginal fornices delineator. Using the incorrect 3.5cm model instead of the required 3.0cm model could lead to improper procedure delineation. This may cause discomfort or minor complications during medical procedures.
Women using the Koh Cup for vaginal procedures may be affected. Those who purchased the 3.5cm model (P/N 34131-04) are most at risk.
Check the model number on the Koh Cup. The affected model is KCP-30-2 with lot number 280819. The incorrect size (3.5cm) was packaged instead of the required 3.0cm.
Look for the model number on the Koh Cup, which should be KCP-30-2 for the affected item.
The 3.5cm model is not the correct size and may cause improper use during vaginal procedures. It is not safe to use as intended.
The recall record does not specify a remedy, so no action is required beyond checking the model number.
The affected model is KCP-30-2 with lot number 280819. Check the model number and lot number on the Koh Cup.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1686-2021 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-1686-2021 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.
