For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Aesculap Implant Systems LLC
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2518-2023
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