Aesculap recalls Strauss Penis Clamp 130MM/General Instruments due to plastic sleeves sticking during reprocessing, making instruments unusable after reprocessing. Affected units include model EF401R.
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Aesculap is recalling Strauss Penis Clamp 130MM/General Instruments because the plastic sleeves can stick together during or after reprocessing, rendering the instruments unusable. This issue affects medical devices used in procedures requiring reprocessing.
The plastic sleeves of the clamp and mouth gag can stick together during or after reprocessing. This makes the instruments unusable for their intended medical purpose, but does not pose a direct risk to users during normal use.
Medical professionals who use the Strauss Penis Clamp 130MM/General Instruments for procedures involving reprocessing. The risk is low as the issue only affects instruments that have been reprocessed.
The recalled product is the Strauss Penis Clamp 130MM/General Instruments with model number EF401R. This was sold by Aesculap Implant Systems LLC.
Look for the model number EF401R on the product label.
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing, rendering the instruments unusable.
The recall does not specify a remedy, so no action is required beyond checking if you have the model EF401R.
The product is safe for use unless it has been reprocessed, in which case the plastic sleeves may stick together and make it unusable.
We’ve drafted a message you can send Aescul: Aesculap Implant Systems LLC to request your refund or repair — edit it as you like.
Subject: Recall Z-1359-2018 — Aescul: Aesculap Implant Systems LLC Aescul: Aesculap Implant Systems LLC Hello, I own a Aescul: Aesculap Implant Systems LLC that is covered by recall Z-1359-2018 from Aescul: Aesculap Implant Systems LLC. 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.
