TEI Biosciences, Inc. recalls TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Siz
Recalled Product
TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 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): 6495-9-001 (10381780113621), 6495-9-004 (10381780113638), 6495-9-006 (10381780113645).
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