PlainRecalls
FDA Devices Moderate Class II Terminated

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).

Reported: July 24, 2019 Initiated: June 14, 2019 #Z-1978-2019

Product Description

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).

Reason for Recall

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.

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
213 units in total
Distribution
US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled? ▼
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).. Recalled by CooperSurgical, Inc.. Units affected: 213 units in total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1978-2019.

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