TEI Biosciences, Inc.: PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 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: 7,264 units Lot/code info: Item No. (UDI-DI): 607-104-125(10381780113775) , 607-104-225 (10381780113782), 607-104-440 (10381780113560), 607-104-660 (10381780113577), 607-104-812 (10381780113768), 607-104-880 (10381780113584).

UPC codes

10381780113775, 10381780113782, 10381780113560, 10381780113577, 10381780113768, 10381780113584

Source

Official record: FDA (Device enforcement) ↗

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