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CooperSurgical, Inc. recalls Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine
Recalled July 24, 2019 · FDA recall Z-1978-2019 · CooperSurgical
Hazard
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. · FDA Class II
Units
213 units in total
Sold at
US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..
Description
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.
Product
Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 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).
Manufacturer(s)
CooperSurgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →