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U.S. Department of Health and Human Services

Class 2 Device Recall Advincula Delineator

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 Class 2 Device Recall Advincula Delineatorsee related information
Date Initiated by FirmJune 14, 2019
Create DateJuly 15, 2019
Recall Status1 Terminated 3 on May 19, 2020
Recall NumberZ-1977-2019
Recall Event ID 83105
510(K)NumberK180429 
Product Classification Culdoscope (and accessories) - Product Code HEW
ProductAdvincula 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).
Code Information Lot 017-19
FEI Number 1216677
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactCustomer Service
203-601-9818
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn June 14, 2019, the firm, CooperSurgical, notified customers of the recall via "URGENT: MEDICAL DEVICE RECALL" letters. Customers were informed that the soft, flexible cup of the Advincula Delineator may crack when subjected to excessive compression during use. The failure mode could lead to serious health consequences such as lacerations. Customers are asked to do the following; - Quarantine affected products - Complete the enclosed Acknowledgement and Receipt form and return to Cooper Surgical via email: recall@coopersurgical.com or fax to 203.601.9870 ATTN: Product Surveillance, even if you do not have affected product. - Once the firm has received your acknowledgement form, it will arrange for product returns and replacements, if requested. If you have questions regarding this recall, you may contact the firm at 2036015200 ext. 3300.
Quantity in Commerce213 units in total
DistributionUS distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HEW
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