PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.

Class I - Dangerous

🏥 Medical Devices Recalled: May 23, 2023 TEI Biosciences Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
Item No. (UDI-DI): 607-001-009 (10381780113294), 607-001-112 (10381780113300), 607-001-125 (10381780113317), 607-001-225 (10381780113324), 607-001-440 (10381780113331), 607-001-660 (10381780113348), 607-001-812 (10381780113355), 607-001-880 (10381780113362).
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:: TEI Biosciences, Inc.
Reason for Recall:: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.

Product Codes/Lot Numbers:

Item No. (UDI-DI): 607-001-009 (10381780113294), 607-001-112 (10381780113300), 607-001-125 (10381780113317), 607-001-225 (10381780113324), 607-001-440 (10381780113331), 607-001-660 (10381780113348), 607-001-812 (10381780113355), 607-001-880 (10381780113362).