TEI Biosciences, Inc. recalls PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x
Recalled Product
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 / Issue
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Issued by
FDA
Distribution: Nationwide (United States)
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).
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