Recall record at a glance
| Official record | Z-1977-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | CooperSurgical, Inc. |
| Report date | Jul 24, 2019 |
| Recall initiation date | Jun 14, 2019 |
| Quantity | 213 units in total |
| Location | Trumbull, CT, United States |
Official 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).
Why the product 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.
Distribution information
US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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