TEI Biosciences, Inc. recalls 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…
- Recall date
- May 23, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2079-2023
- FDA classification
- Class II
- Brand / firm
- TEI Biosciences, Inc.
- Sold / distributed
- Domestic: Nationwide Distribution.
Why it was recalled
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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).
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