For intraventricular indications mainly used for recall
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Why was For intraventricular indications mainly used for recalled?
Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: 04038653065547 Lot Numbers: 52750146 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 52830872. Serial Numbers: 4281,4282, 4284,4288, 4289,4291, 4308,4309, 4310, 4312, 4313,4336, 4340,4341, 4342,4402, 4411, 4412, 4413,4414, 4422,4439, 4447,4449, 4450
- Product
- For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 25 units
- Distribution
- US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
- Recall date
- September 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)