TEI Biosciences, Inc.: 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.

Hazard

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Details from the source

Reason for recall: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Distribution: Domestic: Nationwide Distribution. Quantity: 4,159 units Lot/code info: 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).

UPC codes

10381780113294, 10381780113300, 10381780113317, 10381780113324, 10381780113331, 10381780113348, 10381780113355, 10381780113362

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.