TEI Biosciences, Inc. recalls Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx O
Recalled Product
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
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): 611-001-001 (10381780357292), 611-001-002 (10381780357278), 611-001-003 (10381780357285).
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