Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.

Class I - Dangerous

🏥 Medical Devices Recalled: June 18, 2015 Allergan Implants & Prosthetics

What Should You Do?

Check if you have this product:
Serial No. (Lot No.) VE7507 (5F075-OEM), VE9273 (6H009-OEM), VF4561 (09H024-OEM), VF5340 (10A115-OEM), VE9272 (6H009-OEM), VF3627 (09E231-OEM), VE9117 (6F158-OEM), VF1201 (7K195-OEM), VF5396 (10A182-OEM), VF5341 (10A115-OEM), VF4923 (09J052-OEM), VF1420 (7L085-OEM), VF1327(7L043-OEM), VE7508 (5F075-OEM), VF1427 (7L085-OEM), VE9274 (6H009-OEM).
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:: Allergan Inc
Reason for Recall:: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.

Product Codes/Lot Numbers:

Serial No. (Lot No.) VE7507 (5F075-OEM), VE9273 (6H009-OEM), VF4561 (09H024-OEM), VF5340 (10A115-OEM), VE9272 (6H009-OEM), VF3627 (09E231-OEM), VE9117 (6F158-OEM), VF1201 (7K195-OEM), VF5396 (10A182-OEM), VF5341 (10A115-OEM), VF4923 (09J052-OEM), VF1420 (7L085-OEM), VF1327(7L043-OEM), VE7508 (5F075-OEM), VF1427 (7L085-OEM), VE9274 (6H009-OEM).