CooperSurgical recalls Advincula Delineator size 3.0 cm soft cups due to potential cracking from excessive compressions, which could cause lacerations during uterine procedures.
The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.
CooperSurgical is recalling Advincula Delineator uterine manipulators with Ultem Plastic Soft Cup size 3.0 cm because the soft cup might crack under pressure, risking lacerations. This is a serious hazard for patients undergoing laparoscopic hysterectomies.
The soft cup can crack when subjected to excessive compressions during use, which may cause lacerations. This is a serious health risk during uterine procedures like laparoscopic hysterectomies.
Women undergoing laparoscopic hysterectomies using this specific device are most at risk. The recall applies to the Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm, part number AD750SC-KE30.
Check for the product name 'Advincula Delineator' with Ultem Plastic Soft Cup size 3.0 cm. The part number is AD750SC-KE30, and it was sold with lot number 021-19.
Immediately stop using the Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm if you have it.
The part number is AD750SC-KE30.
The recall record does not mention any remedy or replacement options.
Women undergoing laparoscopic hysterectomies using this specific device are most at risk.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1978-2019 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-1978-2019 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.
