TEI Biosciences, Inc.: PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).

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: 33,277 units Lot/code info: Item No. (UDI-DI): 607-005-225 (10381780113423), 607-005-330 (10381780113430), 607-005-440 (10381780113447), 607-005-550 (10381780113454), 607-005-660 (10381780113461), 607-005-812 (10381780113478), 607-005-880 (10381780113485).

UPC codes

10381780113423, 10381780113430, 10381780113447, 10381780113454, 10381780113461, 10381780113478, 10381780113485

Source

Official record: FDA (Device enforcement) ↗

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