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Class 2 Device Recall Advincula Delineator |
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Date Initiated by Firm |
June 14, 2019 |
Create Date |
July 15, 2019 |
Recall Status1 |
Terminated 3 on May 19, 2020 |
Recall Number |
Z-1977-2019 |
Recall Event ID |
83105 |
510(K)Number |
K180429
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Product Classification |
Culdoscope (and accessories) - Product Code HEW
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Product |
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). |
Code Information |
Lot 017-19 |
Recalling Firm/ Manufacturer |
CooperSurgical, Inc. 95 Corporate Dr Trumbull CT 06611-1350
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For Additional Information Contact |
Customer Service 203-601-9818
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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.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On 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 Commerce |
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.. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = HEW and Original Applicant = CooperSurgical, Inc.
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