Advincula Delineator with Ultem Plastic Soft Cup size 2 recalled over laceration hazard

Recall date

June 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CooperSurgical, Inc. recalls Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Ma…

Recall number

Z-1977-2019

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).