medical Class II Updated 2019-07-24

CooperSurgical, Inc. recalls Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm

Recalled Product

Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, WA
Lot/Code Info: Lot 017-19
View official government recall

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