Z-1977-2019 Class II Terminated
FDA device recall Z-1977-2019 was initiated by CooperSurgical, Inc. on June 14, 2019 and is designated Class II. 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 la… The recall status is terminated (terminated May 19, 2020). Affected quantity: 213 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- June 14, 2019
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 213 units in total
Product Description
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).
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.
Distribution Pattern
US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..
Code Information
Lot 017-19