Recall Z-1978-2019
CooperSurgical, Inc. · initiated June 14, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
Codes / lots: Lot 021-19
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: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1978-2019
- Initiated
- June 14, 2019
- Terminated
- May 19, 2020
- Product code
- HEW – Culdoscope (And Accessories)
- Quantity
- 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..
- Recalling firm
- CooperSurgical, Inc., Trumbull, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1977-2019 Class II | Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The…The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when… | 06/14/2019Terminated |