Advincula Delineator with Ultem Plastic Soft Cup recall
Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use…
Why was Advincula Delineator with Ultem Plastic Soft Cup 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 021-19
- 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…
- Recalling firm
- CooperSurgical, Inc.
- 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..
- Recall date
- July 24, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)